Cleared Traditional

K020257 - DATASCOPE'S 8FR. ALT B IAB

Also marketed or referenced as:
DATASCOPE'S PROFILE 8FR. ALT B IAB DATASCOPE'S TRUE SHEATHLESS DL 9.5 FR. IAB DATASCOPE'S

K020257 is the FDA 510(k) clearance for DATASCOPE'S 8FR. ALT B IAB by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K020257 · Datascope Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
90d
Days
Class 2
Risk

K020257 is an FDA 510(k) clearance for the DATASCOPE'S 8FR. ALT B IAB. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Datascope Corp. (Fairfield, US). The FDA issued a Cleared decision on April 24, 2002 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3535 - 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 Datascope Corp. devices

Submission Details

510(k) Number K020257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2002
Decision Date April 24, 2002
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSP System, Balloon, Intra-aortic And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3535
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DSP System, Balloon, Intra-aortic And Control

All 123
Devices cleared under the same product code (DSP) and FDA review panel - the closest regulatory comparables to K020257.
CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX
K031636 · Datascope Corp. · Aug 2003
DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX
K031569 · Datascope Corp. · Jun 2003
ARROW INTRA-AORTIC BALLOON (IAB) CATHETER WITH A FIBER OPTIC SENSOR AND A MEASUREMENT SYSTEM, MODELS IAB-05830-F,IAB5840
K021462 · Arrow Intl., Inc. · Jun 2002
MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B
K013326 · Datascope Corp. · Nov 2001
ARROW ACAT 2 INTRA-AORTIC BALLOON PUMP
K002256 · Arrow Intl., Inc. · May 2001
ARROW REDIGUARD, 9FR. 50CC, INTRA-AORTIC BALLOON VATHETER, IAB-R950-U
K010330 · Arrow Intl., Inc. · Mar 2001