Cleared Traditional

K083111 - IMPELLA 5.0 CATHETER FAMILY

K083111 is an FDA 510(k) clearance for IMPELLA 5.0 CATHETER FAMILY, manufactured by Abiomed, Inc.. The device is a Class 2 Cardiovascular device with product code KFM cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K083111 · Abiomed, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
177d
Days
Class 2
Risk

K083111 is an FDA 510(k) clearance for the IMPELLA 5.0 CATHETER FAMILY. Classified as Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (product code KFM), Class II - Special Controls.

Submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on April 16, 2009 after a review of 177 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4360 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Abiomed, Inc. devices

FDA 510(k) Submission Details - K083111

510(k) Number K083111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2008
Decision Date April 16, 2009
Days to Decision 177 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 125d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

KFM Device Classification - Class 2, Special Controls

Product Code KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4360
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT00534859 Completed Interventional Industry-sponsored

PROTECT I, A Prospective Feasibility Trial Investigating the Use of IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI

PROTECT I, A Prospective Feasibility Trial Investigating the Use of the IMPELLA RECOVER LP 2.5 System in Patients Undergoing High Risk PCI

28
Patients (actual)
10
Sites
Treatment
Purpose
Open label
Masking
Condition studied Patients Undergoing High Risk PCI.
Study design Single group
Eligibility All sexes · 40 Years+
Principal investigator William O'Neill, M.D.
Sponsor Abiomed Inc. (industry)
Started 2006-08-01 → Primary completion 2010-06-01 → Completed 2011-03-01
Primary outcome
MACCE Events at 30 days or discharge, whichever is longer
Secondary outcome
Other intra-procedural and peri-procedural adverse events
Study completed - no results published. This trial concluded in 2011 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - KFM Pump, Blood, Cardiopulmonary Bypass, Non-roller Type

All 74
Devices cleared under the same product code (KFM) and FDA review panel - the closest regulatory comparables to K083111.
ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
K090515 · Maquet Cardiopulmonary, AG · Dec 2009
LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052
K090051 · Levitronix, LLC · Oct 2009
MECC SET WITH BIOLINE COATING
K083794 · Maquet Cardiopulmonary, AG · Apr 2009
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM
K082321 · Terumo Cardiovascular Systems Corp. · Feb 2009
ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
K080470 · Maquet Cardiopulmonary, AG · Sep 2008
ORQIS EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL BPS-100
K073631 · Orqis Medical Corporation · Jun 2008