Cleared Traditional

K924358 - ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH

K924358 is the FDA 510(k) clearance for ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH by Cook, Inc.. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 267-day FDA review.

K924358 · Cook, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
May 1993
Decision
267d
Days
Class 2
Risk

K924358 is an FDA 510(k) clearance for the ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED. 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 May 20, 1993 after a review of 267 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

Submission Details

510(k) Number K924358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1992
Decision Date May 20, 1993
Days to Decision 267 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
142d slower than avg
Panel avg: 125d · This submission: 267d
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 K924358.
MEADOX SURGIMED BALLOON CATHETER
K923947 · Meadox Medicals, Div. Boston Scientific Corp. · Sep 1993
SCIMED VIPER
K933183 · Scimed Life Systems, Inc. · Sep 1993
MEADOX(R) SURGIMED OLBERT CATHETER SYSTEM(R)
K921706 · Meadox Medicals, Div. Boston Scientific Corp. · May 1993
MAVERICK PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CAT
K925945 · Scimed Life Systems, Inc. · May 1993
BLUE MAX II BALLOON DDILATATION CATHETER
K921254 · Boston Scientific Corp · Dec 1992
BALLOON DILATATION CATHETER
K922610 · Boston Scientific Corp · Nov 1992