510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K080428Substantially Equivalent

Attain Command 6250 Left Heart Delivery Systems and Attain Command 6250 Guide Catheters for Left Heart Delivery

Medtronic, Inc., Mounds View MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080428 is the FDA 510(k) clearance record for ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY, a class II device, cleared for Medtronic, Inc. 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 no recalls naming K080428.

Clearance record

Decision date
Received
(294 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic, Inc. 8200 Coral Sea St. N.E, Mounds View 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 November 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQY, trailing twelve months
MonthClearances
December 20252
January 20260
February 20260
March 20261
April 20262
May 20260
June 20262
July 20263
August 20262
September 20261
October 20260
November 20260