Cleared Traditional

K991102 - COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331

K991102 is an FDA 510(k) clearance for COPILOT BLEEDBACK CONTROL VALVE, manufactured by Guidant Corp.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K991102 · Guidant Corp. · Cardiovascular device
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Jun 1999
Decision
69d
Days
Class 2
Risk

K991102 is an FDA 510(k) clearance for the COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Guidant Corp. (Temecula, US). The FDA issued a Cleared decision on June 9, 1999 after a review of 69 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4290 - 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 Guidant Corp. devices

FDA 510(k) Submission Details - K991102

510(k) Number K991102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1999
Decision Date June 09, 1999
Days to Decision 69 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
56d faster than avg
Panel avg: 125d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTL Device Classification - Class 2, Special Controls

Product Code DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4290
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 - DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

All 103
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K991102.
ADAPTERS WITH X-COATING
K003604 · Terumo Cardiovascular Systems Corp. · Feb 2001
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT
K992906 · Olson Medical Sales, Inc. · Nov 1999
MBA
K993057 · Merit Medical Systems, Inc. · Oct 1999
MANIFOLD
K972654 · Medical Specialties Intl., Inc. · Oct 1997
HIGH PRESSURE INJECTION LINES
K963749 · Maxxim Medical · Dec 1996
NMI VEIN GRAFT PERFUSION SET
K961181 · Naltiac Medical, Inc. · Jun 1996