Cleared Traditional

K030966 - CONTOUR EMBOLI PVA AND FASTRACKER-325 I...

K030966 is the FDA 510(k) clearance for CONTOUR EMBOLI PVA AND FASTRACKER-325 I... by Boston Scientific Corp. It is a Class 2 Obstetrics & Gynecology device (product code NAJ) cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K030966 · Boston Scientific Corp · Obstetrics & Gynecology device
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Sep 2003
Decision
180d
Days
Class 2
Risk

K030966 is an FDA 510(k) clearance for the CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER. Classified as Agents, Embolic, For Treatment Of Uterine Fibroids (product code NAJ), Class II - Special Controls.

Submitted by Boston Scientific Corp (Glens Falls, US). The FDA issued a Cleared decision on September 23, 2003 after a review of 180 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 870.3300 - the FDA obstetrics and gynecology device 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 Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K030966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2003
Decision Date September 23, 2003
Days to Decision 180 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 160d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NAJ Agents, Embolic, For Treatment Of Uterine Fibroids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
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 Obstetrics & Gynecology devices follow this clearance model.

Regulatory Peers - NAJ Agents, Embolic, For Treatment Of Uterine Fibroids

Devices cleared under the same product code (NAJ) and FDA review panel - the closest regulatory comparables to K030966.
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K081768 · Cook Incorporated · Dec 2008