Cleared Traditional

K903417 - VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIO...

K903417 is an FDA 510(k) clearance for VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIO..., manufactured by Vas-Cath, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K903417 · Vas-Cath, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
127d
Days
Class 2
Risk

K903417 is an FDA 510(k) clearance for the VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIOPLASTY CATH. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Vas-Cath, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on December 5, 1990 after a review of 127 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Vas-Cath, Inc. devices

FDA 510(k) Submission Details - K903417

510(k) Number K903417 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 31, 1990
Decision Date December 05, 1990
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIT Device Classification - Class 2, Special Controls

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 261
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K903417.
ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER
K900677 · Cook, Inc. · Feb 1991
SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH
K910155 · Scimed Life Systems, Inc. · Feb 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K905773 · Mallinckrodt Medical · Jan 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH.
K902317 · Mallinckrodt Medical · Dec 1990
OPTI-PLAST 7F PERIPHERAL ANGIOPLASTY CATHETER
K902367 · Vas-Cath, Inc. · Dec 1990
PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER
K900094 · Boston Scientific Corp · Oct 1990