Cleared Traditional

K924358 - ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED

K924358 is an FDA 510(k) clearance for ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, 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 267-day FDA review.

K924358 · Cook, Inc. · Cardiovascular device
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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

FDA 510(k) Submission Details - K924358

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.

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 K924358.
SCIMED VIPER
K933183 · Scimed Life Systems, Inc. · Sep 1993
SCHNEIDER MATCH-35 PERCUTANEOUS TRANSLUMINAL ANGIO
K926271 · Schneider Intl., Ltd. · Jun 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
ACESSORY PACK
K923638 · Medtronics Interventional Vascular · Feb 1993
BLUE MAX II BALLOON DDILATATION CATHETER
K921254 · Boston Scientific Corp · Dec 1992