Cleared Traditional

K961717 - NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS

K961717 is an FDA 510(k) clearance for NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS, manufactured by Naltiac Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K961717 · Naltiac Medical, Inc. · Cardiovascular device
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Jul 1996
Decision
77d
Days
Class 2
Risk

K961717 is an FDA 510(k) clearance for the NMI RETROGRADE CARDIOPLEGIA CANNULA-RCCS. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Naltiac Medical, Inc. (Dallas, US). The FDA issued a Cleared decision on July 18, 1996 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Naltiac Medical, Inc. devices

FDA 510(k) Submission Details - K961717

510(k) Number K961717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1996
Decision Date July 18, 1996
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 317
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K961717.
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BETTER-VENTER
K961594 · Circulatory Technology, Inc. · Sep 1996
RMI HEMOCONCENTRACTOR TUBING SET
K961927 · Research Medical, Inc. · Aug 1996
NMI ANTEGRAD CARDIOPLEGIA CANNULA
K961180 · Naltiac Medical, Inc. · Jun 1996
HEARTPORT ENDOPULMONARY VENT
K961245 · Heartport, Inc. · Jun 1996
HEARTPORT ENDOSINUS CATHETER
K961270 · Heartport, Inc. · Jun 1996