Cleared Traditional

HEADWAY 17 ADVANCED MICROCATHETER (K101542) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K101542 · MicroVention, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 Peers - DQY Catheter, Percutaneous

All 888
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K101542.
Perfect-O Ostial Positioning Catheter
K260289 · Balosmark, Inc. · Jun 2026
Amplatzer TorqVue Delivery System
K260993 · Abbott · Apr 2026
Teleport Glide Microcatheter
K253361 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Apr 2026
Amplatzer™ Trevisio™ Intravascular Delivery System
K260499 · Abbott Medical · Mar 2026
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48)
K253409 · Medtronic, Inc. · Dec 2025
Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)
K252417 · Abbott Medical · Dec 2025