Cleared Traditional

K903632 - INTERSEPT 1375 VENOUS RESERVOIR

K903632 is an FDA 510(k) clearance for INTERSEPT 1375 VENOUS RESERVOIR, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K903632 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
129d
Days
Class 2
Risk

K903632 is an FDA 510(k) clearance for the INTERSEPT 1375 VENOUS RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Medtronic Vascular (Anaheim, US). The FDA issued a Cleared decision on December 17, 1990 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 Vascular devices

FDA 510(k) Submission Details - K903632

510(k) Number K903632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1990
Decision Date December 17, 1990
Days to Decision 129 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 125d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTN Device Classification - Class 2, Special Controls

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 147
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K903632.
MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG
K911790 · Medtronic Vascular · Aug 1991
SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200
K911876 · Shiley, Inc. · Aug 1991
COBE ICU CONVERSION KIT
K902631 · Cobe Laboratories, Inc. · Dec 1990
SOFTSHELL VENOUS RESERVOIR
K904040 · C.R. Bard, Inc. · Dec 1990
CAPIOX HARDSHELL VENOUS RESERVOIR
K894664 · Terumo Medical Corp. · Apr 1990
UNIVOX-IC
K895356 · Baxter Healthcare Corp · Mar 1990