Cleared Traditional

K901287 - INTHERM TEMPORARY OCCLUSION CATHETER

K901287 is an FDA 510(k) clearance for INTHERM TEMPORARY OCCLUSION CATHETER, manufactured by Interventional Therapeutics Corp.. The device is a Class 2 Cardiovascular device with product code DYG cleared through the Traditional 510(k) pathway after a 337-day FDA review.

K901287 · Interventional Therapeutics Corp. · Cardiovascular device
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Feb 1991
Decision
337d
Days
Class 2
Risk

K901287 is an FDA 510(k) clearance for the INTHERM TEMPORARY OCCLUSION CATHETER. Classified as Catheter, Flow Directed (product code DYG), Class II - Special Controls.

Submitted by Interventional Therapeutics Corp. (Mountain View, US). The FDA issued a Cleared decision on February 20, 1991 after a review of 337 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1240 - 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. Elevated predicate reliance profile. 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 Interventional Therapeutics Corp. devices

FDA 510(k) Submission Details - K901287

510(k) Number K901287 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1990
Decision Date February 20, 1991
Days to Decision 337 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
212d slower than avg
Panel avg: 125d · This submission: 337d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYG Device Classification - Class 2, Special Controls

Product Code DYG Catheter, Flow Directed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1240
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 - DYG Catheter, Flow Directed

All 67
Devices cleared under the same product code (DYG) and FDA review panel - the closest regulatory comparables to K901287.
SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT
K934742 · Baxter Healthcare Corp · Jan 1994
SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER
K924452 · Baxter Healthcare Corp · Oct 1993
INTERFLO MEDICAL MODEL PA3-H CCO/PAC CATHETER
K911840 · Intec Medical, Inc. · Jun 1991
STEALTH DILATION CATHETER SYSTEM/MODIFICATION
K904287 · Target Therapeutics · Jan 1991
TRI ADAPTER W/ADJUSTABLE HEMOSTASIS VALVES
K901247 · Intec Medical, Inc. · Jul 1990
SOFT-WEDGE(TM) SYRINGE
K900879 · Baxter Healthcare Corp · May 1990