Cleared Traditional

K950398 - CATHETER, BALLOON TYPE

K950398 is an FDA 510(k) clearance for CATHETER, manufactured by Interventional Therapeutics Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 246-day FDA review.

K950398 · Interventional Therapeutics Corp. · Cardiovascular device
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Oct 1995
Decision
246d
Days
Class 2
Risk

K950398 is an FDA 510(k) clearance for the CATHETER, BALLOON TYPE. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Interventional Therapeutics Corp. (Fremont, US). The FDA issued a Cleared decision on October 5, 1995 after a review of 246 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Interventional Therapeutics Corp. devices

FDA 510(k) Submission Details - K950398

510(k) Number K950398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1995
Decision Date October 05, 1995
Days to Decision 246 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
121d slower than avg
Panel avg: 125d · This submission: 246d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 369
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K950398.
BRUN SELECTIVE AND FLUSH ANGIOGRAPHIC CATHETERS
K955485 · B.Braun Medical, Inc. · Feb 1996
ANGIOPTIC ANGIOGRAPHIC CATHETER
K954423 · AngioDynamics, Inc. · Dec 1995
MIKRO-TIP ANGIOGRAPHIC CATHETER
K952773 · Millar Instruments, Inc. · Nov 1995
DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
K950440 · J-Lloyd Medical, Inc. · Sep 1995
EVOLUTION MICROCATHETER
K953114 · Boston Scientific Corp · Sep 1995
BRAUN SELECTIVE ANGIOGRAPHIC CATHETER
K950882 · B.Braun Medical, Inc. · Aug 1995