Cleared Traditional

K070770 - GORE BALLOON SHEATH

K070770 is the FDA 510(k) clearance for GORE BALLOON SHEATH by W.L. Gore & Associates, Inc.. It is a Class 2 Cardiovascular device (product code MJN) cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K070770 · W.L. Gore & Associates, Inc. · Cardiovascular device
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Jun 2007
Decision
101d
Days
Class 2
Risk

K070770 is an FDA 510(k) clearance for the GORE BALLOON SHEATH. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Pleasanton, US). The FDA issued a Cleared decision on June 29, 2007 after a review of 101 days - within the typical 510(k) review window.

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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K070770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2007
Decision Date June 29, 2007
Days to Decision 101 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
24d faster than avg
Panel avg: 125d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 54
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