Cleared Special

K261631 - Amplatzer TorqVue Exchange System

K261631 is an FDA 510(k) clearance for Amplatzer TorqVue Exchange System, manufactured by Abbott Medical. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 30-day FDA review.

K261631 · Abbott Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
30d
Days
Class 2
Risk

K261631 is an FDA 510(k) clearance for the Amplatzer TorqVue Exchange System. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Abbott Medical (Saint Paul, US). The FDA issued a Cleared decision on June 17, 2026 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Abbott Medical devices

FDA 510(k) Submission Details - K261631

510(k) Number K261631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2026
Decision Date June 17, 2026
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

DQY Device Classification - Class 2, Special Controls

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 621
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K261631.
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