510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K021587Substantially Equivalent

Attain Lds 6216A Left-Heart Delivery System, Model 6216A

Medtronic, Inc., Minneapolis MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021587 is the FDA 510(k) clearance record for ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A, a class II device, cleared for Medtronic Vascular on under FDA product code DQY (Catheter, Percutaneous). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show one recall naming K021587.

Clearance record

Decision date
Received
(15 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic Vascular 7000 Central Ave., NE, Minneapolis 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