Cleared Traditional

K993292 - BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER

K993292 is an FDA 510(k) clearance for BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSI..., manufactured by Boston Scientific, Target. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K993292 · Boston Scientific, Target · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2000
Decision
174d
Days
Class 2
Risk

K993292 is an FDA 510(k) clearance for the BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Boston Scientific, Target (Fremont, US). The FDA issued a Cleared decision on March 23, 2000 after a review of 174 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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.

FDA 510(k) Submission Details - K993292

510(k) Number K993292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1999
Decision Date March 23, 2000
Days to Decision 174 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
49d slower than avg
Panel avg: 125d · This submission: 174d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MJN Device Classification - Class 2, Special Controls

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - MJN Catheter, Intravascular Occluding, Temporary

All 89
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K993292.
AMPLATZER SIZING BALLOON
K993248 · Aga Medical Corp. · Jul 2000
EQUINOX OCCLUSION BALLOON CATHETER/SYSTEM - (10MM BALLOON, 4 & 13 MM TIP), (15 MM BALLOON, 4 & 13 MM TIP), (20 MM BALLOO
K001237 · Micro Therapeutics, Inc. · May 2000
LEMAITRE OCCLUSION CATHETER
K992942 · Vascutech, Inc. · Apr 2000
EQUINOX OCCLUSION BALLOON SYSTEM
K990487 · Micro Therapeutics, Inc. · Aug 1999
LMI CAROTID ENDARTERECTOMY SHUNT CATHETER, MODEL #'S CES, CESR, CESB, CESRB, CEST, CESTR, CESTB, CESTRB, CES-SB, CESR-SB
K983802 · Lucas Medical, Inc. · Jul 1999
TEMPORARY OCCLUSION BALLOON SYSTEM
K972777 · Percu Surge, Inc. · Mar 1998
K993292 · BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER
Download PDF FDA Summary Boston Scientific, Ta…