Cleared Traditional

K922610 - BALLOON DILATATION CATHETER

K922610 is the FDA 510(k) clearance for BALLOON DILATATION CATHETER by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K922610 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
169d
Days
Class 2
Risk

K922610 is an FDA 510(k) clearance for the BALLOON DILATATION CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on November 18, 1992 after a review of 169 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 Boston Scientific Corp devices

Submission Details

510(k) Number K922610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1992
Decision Date November 18, 1992
Days to Decision 169 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
44d slower than avg
Panel avg: 125d · This submission: 169d
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 238
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K922610.
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
SHORT TEGWIRE -- MODIFIED
K924276 · Boston Scientific Corp · Nov 1992
SUB-4 SMALL VESSEL BALLOON DILATATION CATHETER
K924047 · Boston Scientific Corp · Nov 1992
PARAMETRIC PROCESS CONTROL
K923826 · Scimed Life Systems, Inc. · Oct 1992