510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K944966Substantially Equivalent

Unipolar Atrial Temporary Pacing Lead,model 6492

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

K944966 is the FDA 510(k) clearance record for UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492, a class II device, cleared for Medtronic Blood Systems, Inc. on under FDA product code LDF (Electrode, Pacemaker, Temporary). FDA records list 15 510(k) clearances for Medtronic Blood Systems, Inc., from to . As of , FDA records show no recalls naming K944966.

Clearance record

Decision date
Received
(276 days to decision)
Product code
LDF Electrode, Pacemaker, Temporary
Regulation
21 CFR 870.3680
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic Blood Systems, Inc. 7000 Central Ave., NE, Minneapolis MN
510(k) summary
Summary
Third party review
No

Clearances, product code LDF

Trailing 12 months
1 clearance under product code LDF in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LDF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260