Cleared Traditional

K991977 - TYSHAK

K991977 is the FDA 510(k) clearance for TYSHAK by NuMED, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 474-day FDA review.

K991977 · NuMED, Inc. · Cardiovascular device
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Sep 2000
Decision
474d
Days
Class 2
Risk

K991977 is an FDA 510(k) clearance for the TYSHAK, MODEL 102 AND Z-MED, MODEL 302. 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 September 27, 2000 after a review of 474 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all NuMED, Inc. devices

Submission Details

510(k) Number K991977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1999
Decision Date September 27, 2000
Days to Decision 474 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
349d slower than avg
Panel avg: 125d · This submission: 474d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 243
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K991977.
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K003159 · Cordis Corp. · Oct 2000
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K001134 · Boston Scientific Corp · Aug 2000
PTA BALLOON CATHETER
K001087 · Cook, Inc. · Jul 2000
TALON BALLOON DILATION CATHETER
K000798 · Boston Scientific Corp · Jun 2000