Cleared Traditional

K021996 - BOLTON PTA CATHETER

K021996 is an FDA 510(k) clearance for BOLTON PTA CATHETER, manufactured by Bolton Medical, Inc.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K021996 · Bolton Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
66d
Days
Class 2
Risk

K021996 is an FDA 510(k) clearance for the BOLTON PTA CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Bolton Medical, Inc. (Fair Lawn, US). The FDA issued a Cleared decision on August 23, 2002 after a review of 66 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K021996

510(k) Number K021996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2002
Decision Date August 23, 2002
Days to Decision 66 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
59d faster than avg
Panel avg: 125d · This submission: 66d
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 404
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K021996.
POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM
K030742 · Cryo Vascular Systems, Inc. · Aug 2003
ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0
K030062 · Avantec Vascular Corp. · Apr 2003
MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER
K023504 · Cook, Inc. · Nov 2002
MODIFICATION TO FOX PTA CATHETER
K020854 · Jomed AG · Apr 2002
NUMED GHOST II PTA CATHETERS
K003972 · NuMED, Inc. · Jan 2001
TYSHAK MINI PEDIATRIC PTV CATHETER, MODEL 107
K003276 · NuMED, Inc. · Dec 2000
K021996 · BOLTON PTA CATHETER
Download PDF FDA Summary Bolton Medical, Inc.