Cleared Traditional

K921399 - OCCLUSION BALLON CATHETER MODIFICAION

K921399 is an FDA 510(k) clearance for OCCLUSION BALLON CATHETER MODIFICAION, manufactured by Interventional Therapeutics Corp.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K921399 · Interventional Therapeutics Corp. · Cardiovascular device
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Sep 1992
Decision
185d
Days
Class 2
Risk

K921399 is an FDA 510(k) clearance for the OCCLUSION BALLON CATHETER MODIFICAION. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Interventional Therapeutics Corp. (South San Francisco, US). The FDA issued a Cleared decision on September 25, 1992 after a review of 185 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 - K921399

510(k) Number K921399 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1992
Decision Date September 25, 1992
Days to Decision 185 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
60d slower than avg
Panel avg: 125d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 100
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K921399.
FLO-RESTER DISPOSABLE VESSEL OCCLUDER
K942812 · Bio-Vascular, Inc. · Aug 1994
COMPRESSAR UNIVERSAL (TM) SYSTEM
K925809 · Instromedix, Inc. · Feb 1993
RMI EXTERNAL CORONARY ARTERY OCCLUDER
K920936 · Research Medical, Inc. · Dec 1992
SILCLAMPS DEGANIA SILICONE
K920501 · Puritas Health Care, Inc. · Jun 1992
FEMOSTOP
K915280 · Radi Medical Systems AB · Apr 1992
RMI VASCULAR TOURNIQUET KIT
K910221 · Research Medical, Inc. · May 1991