Cleared Traditional

K923638 - ACESSORY PACK

K923638 is an FDA 510(k) clearance for ACESSORY PACK, manufactured by Medtronics Interventional Vascular. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K923638 · Medtronics Interventional Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1993
Decision
202d
Days
Class 2
Risk

K923638 is an FDA 510(k) clearance for the ACESSORY PACK. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Medtronics Interventional Vascular (Danvers, US). The FDA issued a Cleared decision on February 8, 1993 after a review of 202 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 Medtronics Interventional Vascular devices

FDA 510(k) Submission Details - K923638

510(k) Number K923638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 1992
Decision Date February 08, 1993
Days to Decision 202 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
77d slower than avg
Panel avg: 125d · This submission: 202d
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 277
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K923638.
MEADOX(R) SURGIMED OLBERT CATHETER SYSTEM(R)
K921706 · Meadox Medicals, Div. Boston Scientific Corp. · May 1993
ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED
K924358 · Cook, Inc. · 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
SHORT TEGWIRE -- MODIFIED
K924276 · Boston Scientific Corp · Nov 1992