Cleared Traditional

K001662 - CHASE CARDIOVASCULAR PATCH

K001662 is an FDA 510(k) clearance for CHASE CARDIOVASCULAR PATCH, manufactured by Chase Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXZ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K001662 · Chase Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 2000
Decision
63d
Days
Class 2
Risk

K001662 is an FDA 510(k) clearance for the CHASE CARDIOVASCULAR PATCH. Classified as Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene (product code DXZ), Class II - Special Controls.

Submitted by Chase Medical, Inc. (Richardson, US). The FDA issued a Cleared decision on August 2, 2000 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3470 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Chase Medical, Inc. devices

FDA 510(k) Submission Details - K001662

510(k) Number K001662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2000
Decision Date August 02, 2000
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXZ Device Classification - Class 2, Special Controls

Product Code DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3470
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 - DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

All 77
Devices cleared under the same product code (DXZ) and FDA review panel - the closest regulatory comparables to K001662.
CHASE CARDIOVASCULAR PATCH
K003467 · Chase Medical, Inc. · Jan 2001
SURGISIS PERIPHERAL VASCULAR PATCH
K001785 · Cook Biotech, Inc. · Dec 2000
ETHIBOND EXCEL VALVE LOOP SUTURE
K003070 · Ethicon, Inc. · Nov 2000
FLUORO-TEX CARDIOVASCULAR PATCH
K994032 · Bridger Biomed, Inc. · Jul 2000
SULZER CARBOMEDICS CARDIOFIX PERICARDIUM
K993288 · Sulzer Carbomedics, Inc. · Dec 1999
UNI-GRAFT K DV PATCH
K992776 · Atrium Medical Corp. · Nov 1999