Cleared Traditional

K900677 - ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER

K900677 is an FDA 510(k) clearance for ACCENT DG(TM) BALLOON ANGIOPLASTY 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 375-day FDA review.

K900677 · Cook, Inc. · Cardiovascular device
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Feb 1991
Decision
375d
Days
Class 2
Risk

K900677 is an FDA 510(k) clearance for the ACCENT DG(TM) BALLOON ANGIOPLASTY 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 February 22, 1991 after a review of 375 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 Cook, Inc. devices

FDA 510(k) Submission Details - K900677

510(k) Number K900677 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1990
Decision Date February 22, 1991
Days to Decision 375 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
250d slower than avg
Panel avg: 125d · This submission: 375d
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 K900677.
TEGWIRE (TM)
K911203 · Boston Scientific Corp · Apr 1991
OWENS CATHETER
K896520 · Boston Scientific Corp · Mar 1991
MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM)
K904410 · Meadox Medicals, Div. Boston Scientific Corp. · Mar 1991
SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH
K910155 · Scimed Life Systems, Inc. · Feb 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
K905773 · Mallinckrodt Medical · Jan 1991
VAS-CATH OPTI-PLAST 5F PERIPHERAL ANGIOPLASTY CATH
K903417 · Vas-Cath, Inc. · Dec 1990