Cleared Traditional

K033085 - PORTACLAMP

K033085 is an FDA 510(k) clearance for PORTACLAMP, manufactured by Cardio Life Research, S.A.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K033085 · Cardio Life Research, S.A. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
211d
Days
Class 2
Risk

K033085 is an FDA 510(k) clearance for the PORTACLAMP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Cardio Life Research, S.A. (North Attleboro, US). The FDA issued a Cleared decision on April 27, 2004 after a review of 211 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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.

FDA 510(k) Submission Details - K033085

510(k) Number K033085 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2003
Decision Date April 27, 2004
Days to Decision 211 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
86d slower than avg
Panel avg: 125d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 199
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K033085.
VASOSTASIS VASCULAR CLOSURE SYSTEM
K041486 · Cardiva Medical, Inc. · Oct 2004
VASCULAR SOLUTIONS D-STAT CLAMP HEMOSTATIC CLAMP
K040730 · Vascular Solutions, Inc. · Jun 2004
COMPRESSAR SUPERCOMFORT DISC AND STRONGARM SUPERCOMFORT SYSTEM
K040615 · Advanced Vascular Dynamics · Jun 2004
CSTAT, MODELS 09-0014-01 AND 09-0014-02
K032125 · Vascular Control Systems, Inc. · Feb 2004
TRANSVAGINAL DOPPLER CLAMP, MODELS: 09-0016-01, 09-0016-02, 09-0016-03
K031812 · Vascular Control Systems, Inc. · Dec 2003
ENCLOSE II ANASTOMOSIS ASSIST DEVICE
K032589 · Novare Surgical Systems, Inc. · Sep 2003
K033085 · PORTACLAMP
Download PDF FDA Summary Cardio Life Research,…