510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K101982Substantially Equivalent

Merlin Psa Patient Cable Ex 3150, Cable Adapter Ex3170, M Adapter Ex3180

Abbott Medical, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K101982 is the FDA 510(k) clearance record for MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180, a class II device, cleared for St Jude Medical, Crmd on under FDA product code DTA (Tester, Pacemaker Electrode Function). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K101982.

Clearance record

Decision date
Received
(160 days to decision)
Product code
DTA Tester, Pacemaker Electrode Function
Regulation
21 CFR 870.3720
Device class
Class II
Review panel
Cardiovascular
Applicant
St Jude Medical, Crmd 701 E. Evelyn Ave., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTA

Trailing 12 months

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

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