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510(k) K163008

CareLink SmartSync Device Manager - Pacing System Analyzer by Medtronic, Inc. — Product Code DTA

K163008 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "CareLink SmartSync Device Manager - Pacing System Analyzer". The FDA issued a decision of Substantially Equivalent on February 28, 2017. The device falls under product code DTA (Tester, Pacemaker Electrode Function), a Class II device regulated under 21 CFR 870.3720. Medtronic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2017
Date Received
October 28, 2016
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

Other clearances by Medtronic, Inc.

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  • K262005 — Affera Integrated Mapping System (August 21, 2026)
  • K261335 — VitalFlow Set with Balance™ Biosurface (July 31, 2026)
  • K261866 — Concerto Versa™ Detachable Coil (June 24, 2026)
  • K253530 — Trexon™ Monofilament Synthetic Absorbable Suture (May 28, 2026)
  • K260195 — Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae (April 23, 2026)
  • K253203 — Retrograde Coronary Sinus Perfusion Cannulae (February 19, 2026)
  • K253998 — Clearview Intracoronary Shunts (January 20, 2026)
  • K251744 — Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Ar (January 16, 2026)

Other clearances for product code DTA

  • K101982 — MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 (December 21, 2010)
  • 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