Cleared Traditional

K972777 - TEMPORARY OCCLUSION BALLOON SYSTEM

K972777 is an FDA 510(k) clearance for TEMPORARY OCCLUSION BALLOON SYSTEM, manufactured by Percu Surge, Inc.. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 229-day FDA review.

K972777 · Percu Surge, Inc. · Cardiovascular device
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Mar 1998
Decision
229d
Days
Class 2
Risk

K972777 is an FDA 510(k) clearance for the TEMPORARY OCCLUSION BALLOON SYSTEM. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Percu Surge, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on March 11, 1998 after a review of 229 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.

View all Percu Surge, Inc. devices

FDA 510(k) Submission Details - K972777

510(k) Number K972777 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received July 25, 1997
Decision Date March 11, 1998
Days to Decision 229 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 125d · This submission: 229d
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 62
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K972777.
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
BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER
K993292 · Boston Scientific, Target · Mar 2000
EQUINOX OCCLUSION BALLOON SYSTEM
K990487 · Micro Therapeutics, Inc. · Aug 1999
CHASE VESSEL OCCLUDER
K964390 · Chase Medical, Inc. · Jan 1997
OCCLUSION BALLOON CATHETER
K960832 · Interventional Therapeutics Corp. · May 1996
RMI NORMOCLUDER CORONARY ARTERY OCCLUDER
K915869 · Research Medical, Inc. · Dec 1992