510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894976Substantially Equivalent

Alternate Packaging Conf. of Pacemaker Lead Adap.

Medtronic, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894976 is the FDA 510(k) clearance record for ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP., a class II device, cleared for Medtronic Vascular on under FDA product code DTD (Pacemaker Lead Adaptor). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K894976.

Clearance record

Decision date
Received
(66 days to decision)
Product code
DTD Pacemaker Lead Adaptor
Regulation
21 CFR 870.3620
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic Vascular 7000 Central Ave., NE, Minneapolis MN
Third party review
No

Clearances, product code DTD

Trailing 12 months

FDA records hold no clearances under product code DTD in the trailing twelve months.

FDA records show no clearances under product code DTD in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DTD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260