Cleared Traditional

K980390 - PTA BALLOON CATHETER

K980390 is an FDA 510(k) clearance for PTA BALLOON CATHETER, manufactured by Cook, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K980390 · Cook, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
199d
Days
Class 2
Risk

K980390 is an FDA 510(k) clearance for the PTA BALLOON CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cook, Inc. (Bloomington, US). The FDA issued a Cleared decision on August 20, 1998 after a review of 199 days - an extended review cycle.

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 Cook, Inc. devices

FDA 510(k) Submission Details - K980390

510(k) Number K980390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1998
Decision Date August 20, 1998
Days to Decision 199 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
74d slower than avg
Panel avg: 125d · This submission: 199d
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 K980390.
COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER
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BIPORE BALLOON DILATATION CATHETER
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RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003
K983055 · Guidant Corp. · Dec 1998
MODIFICATION FOR PTA BALLOON CATHETER
K981906 · Cook, Inc. · Jun 1998
OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER
K973013 · Vas-Cath, Inc. · Jun 1998
OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER
K981407 · Cordis Corp. · May 1998