Cleared Traditional

K953564 - MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE

K953564 is an FDA 510(k) clearance for MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE, manufactured by Medtronic Cardiac Surgery, Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code DTL cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K953564 · Medtronic Cardiac Surgery, Medtronic, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
186d
Days
Class 2
Risk

K953564 is an FDA 510(k) clearance for the MEDTRONIC OVERPRESSURE/VACUUM RELIEF VALVE. Classified as Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (product code DTL), Class II - Special Controls.

Submitted by Medtronic Cardiac Surgery, Medtronic, Inc. (Anaheim, US). The FDA issued a Cleared decision on February 2, 1996 after a review of 186 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Cardiac Surgery, Medtronic, Inc. devices

FDA 510(k) Submission Details - K953564

510(k) Number K953564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1995
Decision Date February 02, 1996
Days to Decision 186 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
61d slower than avg
Panel avg: 125d · This submission: 186d
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 96
Devices cleared under the same product code (DTL) and FDA review panel - the closest regulatory comparables to K953564.
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HEMO-VALVE
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K954284 · Medi-Plast Intl., Inc. · Feb 1996
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