Cleared Traditional

POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF (K912076) - FDA 510(k) Clearance

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

K912076 · The R Group · Cardiovascular device
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Jul 1991
Decision
81d
Days
Class 2
Risk

K912076 is an FDA 510(k) clearance for the POLY BRAIDED PIGTAIL/PERC CARD CATH W/VAR TIP CONF. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by The R Group (Gainesvilles, US). The FDA issued a Cleared decision on July 30, 1991 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 The R Group devices

Submission Details

510(k) Number K912076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1991
Decision Date July 30, 1991
Days to Decision 81 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 155
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K912076.
MERIT CUSTOM KIT
K913682 · Merit Medical Systems, Inc. · Nov 1991
CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER
K914141 · Cordis Corp. · Oct 1991
CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH
K914007 · Cordis Corp. · Oct 1991
CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER
K911703 · Cordis Corp. · Jun 1991
BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH
K911367 · Baxter Healthcare Corp · Jun 1991
SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM)
K910204 · Baxter Healthcare Corp · Apr 1991