Cleared Traditional

K931009 - TYSHAK PERIPHERAL BALLOON DILATION CATHETER

K931009 is an FDA 510(k) clearance for TYSHAK PERIPHERAL BALLOON DILATION CATHETER, manufactured by NuMED, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 305-day FDA review.

K931009 · NuMED, Inc. · Cardiovascular device
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Dec 1993
Decision
305d
Days
Class 2
Risk

K931009 is an FDA 510(k) clearance for the TYSHAK PERIPHERAL BALLOON DILATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on December 21, 1993 after a review of 305 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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 NuMED, Inc. devices

FDA 510(k) Submission Details - K931009

510(k) Number K931009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1993
Decision Date December 21, 1993
Days to Decision 305 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
180d slower than avg
Panel avg: 125d · This submission: 305d
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 347
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K931009.
SCIMED MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER
K934378 · Scimed Life Systems, Inc. · Jan 1994
MEADOX SURGIMED OLBERT CATHETER SYSTEM NOPROFILE
K934411 · Meadox Medicals, Div. Boston Scientific Corp. · Jan 1994
CORDIS OPTA 5(TM), MODIFICATION
K933236 · Cordis Corp. · Dec 1993
NEW BLUE MAX BALLOON DILATATION CATHETER
K934191 · Boston Scientific Corp · Dec 1993
VANTAGE DIALTAION CATHETER
K934433 · Peripheral Systems Group · Dec 1993
SCIMED MAVERICK PTA CATHETER
K932537 · Scimed Life Systems, Inc. · Dec 1993