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510(k) K101982

MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 by St Jude Medical, Crmd — Product Code DTA

K101982 is an FDA 510(k) premarket notification submitted by St Jude Medical, Crmd for the device "MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180". The FDA issued a decision of Substantially Equivalent on December 21, 2010. The device falls under product code DTA (Tester, Pacemaker Electrode Function), a Class II device regulated under 21 CFR 870.3720.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2010
Date Received
July 14, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Pacemaker Electrode Function
Device Class
Class II
Regulation Number
870.3720
Review Panel
CV
Submission Type

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  • K073230 — MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS (December 20, 2007)
  • K050884 — ADAPTER CABLE (May 19, 2005)
  • K033613 — MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER (December 8, 2003)
  • K022360 — ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA (January 27, 2003)
  • K933069 — MODEL EP-2 CLINICAL STIMULATOR (October 21, 1993)
  • K812104 — SIEMENS-ELEMA PSA 376 (December 2, 1981)
  • K791380 — VA 1000 (September 19, 1979)
  • K790503 — CARDIOTEST 2200 (May 17, 1979)

FDA data resources