Cleared Special

K083214 - AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100

K083214 is an FDA 510(k) clearance for AMPLATZER TORQVUE 45DEGREEX45DEGREE DEL..., manufactured by Aga Medical Corp.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Special 510(k) pathway after a 193-day FDA review.

K083214 · Aga Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
193d
Days
Class 2
Risk

K083214 is an FDA 510(k) clearance for the AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-10.... Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Aga Medical Corp. (Plymouth, US). The FDA issued a Cleared decision on May 12, 2009 after a review of 193 days - an extended review 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. Standard predicate reliance. 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 - K083214

510(k) Number K083214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2008
Decision Date May 12, 2009
Days to Decision 193 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
68d slower than avg
Panel avg: 125d · This submission: 193d
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 861
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K083214.
THE CROSSER 14 OTW CATHETER, MODEL CRU014
K091254 · Flowcardia, Inc. · May 2009
ENABLER-P CATHETER, 1000 PART NUMBER:1160
K083833 · Endocross, Ltd. · May 2009
BRIDGEPOINT MEDICAL CROSSBOSS PERCUTANEOUS CORONARY CATHETER
K081130 · Bridgepoint Medical · May 2009
HD GUIDE CATHETER
K090335 · Concentric Medical, Inc. · May 2009
CROSS-PILOT TURBO ELITE SUPPORT CATHETER
K090913 · Spectranetics Corp. · May 2009
MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150
K090849 · Ev3, Inc. · May 2009
K083214 · AMPLATZER TORQVUE 45DEGREEX45DEGREE DELIVERY SHEATH, MODELS 9-TV45X45-09F-100, 9-TV45X45-10F-100
Download PDF FDA Summary Aga Medical Corp.