Cleared Special

K163000 - AMPLATZER TorqVue 45x45 Delivery Sheath

K163000 is an FDA 510(k) clearance for AMPLATZER TorqVue 45x45 Delivery Sheath, manufactured by Aga Medical COrporation (Wholly Owned by St. Jude Medical CO. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 56-day FDA review.

K163000 · Aga Medical COrporation (Wholly Owned by St. Jude Medical CO · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2016
Decision
56d
Days
Class 2
Risk

K163000 is an FDA 510(k) clearance for the AMPLATZER TorqVue 45x45 Delivery Sheath. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Aga Medical COrporation (Wholly Owned by St. Jude Medical CO (Plymouth, US). The FDA issued a Cleared decision on December 23, 2016 after a review of 56 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.

FDA 510(k) Submission Details - K163000

510(k) Number K163000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 2016
Decision Date December 23, 2016
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 855
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K163000.
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