Cleared Traditional

K121785 - SCEPTER C OCCLUSION BALLOON CATHETER

K121785 is an FDA 510(k) clearance for SCEPTER C OCCLUSION BALLOON CATHETER, manufactured by MicroVention, Inc.. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K121785 · MicroVention, Inc. · Cardiovascular device
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Aug 2012
Decision
53d
Days
Class 2
Risk

K121785 is an FDA 510(k) clearance for the SCEPTER C OCCLUSION BALLOON CATHETER. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on August 10, 2012 after a review of 53 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all MicroVention, Inc. devices

FDA 510(k) Submission Details - K121785

510(k) Number K121785 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2012
Decision Date August 10, 2012
Days to Decision 53 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
72d faster than avg
Panel avg: 125d · This submission: 53d
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 69
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K121785.
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K110903 · NuMED, Inc. · Apr 2011