Cleared Traditional

K945461 - PITON(TM) Y-PACK AND PITON(TM) TRI-PACK)

K945461 is an FDA 510(k) clearance for PITON(TM) Y-PACK AND PITON(TM) TRI-PACK), manufactured by Medtronics Interventional Vascular. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K945461 · Medtronics Interventional Vascular · Cardiovascular device
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Feb 1995
Decision
88d
Days
Class 2
Risk

K945461 is an FDA 510(k) clearance for the PITON(TM) Y-PACK AND PITON(TM) TRI-PACK). Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Medtronics Interventional Vascular (Danvers, US). The FDA issued a Cleared decision on February 3, 1995 after a review of 88 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 Medtronics Interventional Vascular devices

FDA 510(k) Submission Details - K945461

510(k) Number K945461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 1994
Decision Date February 03, 1995
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 90
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K945461.
QUEST VEIN GRAFT PERFUSION SET
K952531 · Quest Medical, Inc. · Aug 1995
BRAUN MANIFOLD
K942391 · B.Braun Medical, Inc. · Jun 1995
SCIMED GATEWAY PLUS
K951089 · Scimed Life Systems, Inc. · May 1995
ADVANCE PRESSURE MONITOR/HIGH PRESSURE LINES
K911884 · Advance Medical Designs, Inc. · Jul 1994
CHECK VALVE (FITTING)
K933084 · Merit Medical Systems, Inc. · Mar 1994
STOPCOCK (ONE-PORT MANIFOLD)
K934123 · Merit Medical Systems, Inc. · Nov 1993