510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K163000Substantially Equivalent

AMPLATZER TorqVue 45x45 Delivery Sheath

Aga Medical Corporation (Wholly Owned by St. Jude Medical Co, Plymouth MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163000 is the FDA 510(k) clearance record for AMPLATZER TorqVue 45x45 Delivery Sheath, a class II device, cleared for Aga Medical COrporation (Wholly Owned by St. Jude Medical CO on under FDA product code DQY (Catheter, Percutaneous). FDA records list one 510(k) clearance for Aga Medical COrporation (Wholly Owned by St. Jude Medical CO. As of , FDA records show no recalls naming K163000.

Clearance record

Decision date
Received
(56 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Aga Medical COrporation (Wholly Owned by St. Jude Medical CO 5050 Nathan Ln., Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQY

Trailing 12 months
13 clearances under product code DQY in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20261
April 20262
May 20260
June 20262
July 20263
August 20262
September 20261
October 20260