Cleared Traditional

K101542 - HEADWAY 17 ADVANCED MICROCATHETER

K101542 is the FDA 510(k) clearance for HEADWAY 17 ADVANCED MICROCATHETER by MicroVention, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K101542 · MicroVention, Inc. · Cardiovascular device
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Aug 2010
Decision
64d
Days
Class 2
Risk

K101542 is an FDA 510(k) clearance for the HEADWAY 17 ADVANCED MICROCATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on August 6, 2010 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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

Submission Details

510(k) Number K101542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 2010
Decision Date August 06, 2010
Days to Decision 64 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQY Catheter, Percutaneous

All 540
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