Cleared Traditional

BREVET DISPOSABLE CONNECTORS (K895753) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K895753 · Brevet, Inc. · Cardiovascular device
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Nov 1989
Decision
49d
Days
Class 2
Risk

K895753 is an FDA 510(k) clearance for the BREVET DISPOSABLE CONNECTORS. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Brevet, Inc. (Anahem, US). The FDA issued a Cleared decision on November 14, 1989 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Brevet, Inc. devices

Submission Details

510(k) Number K895753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1989
Decision Date November 14, 1989
Days to Decision 49 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 125d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 308
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K895753.
VASCULAR RETRIEVAL FORCEPS
K902999 · Cook, Inc. · Feb 1991
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K902905 · Cook, Inc. · Sep 1990
QUINTON MAHURKAR CATHETERS W/VITACUFF
K895440 · Quinton, Inc. · Nov 1989
USCI UNCOATED GUIDING CATHETERS
K894682 · C.R. Bard, Inc. · Sep 1989
USCI PROBING CATHETER
K890152 · C.R. Bard, Inc. · Aug 1989
USCI CORONARY INFUSION CATHETER
K891069 · C.R. Bard, Inc. · Aug 1989