Home / 510(k) Clearances / K033613

510(k) K033613

MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER by Biotronik, Inc. — Product Code DTA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 8, 2003
Date Received
November 17, 2003
Clearance Type
Special
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 Biotronik, Inc.

  • K250706 — Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Ca (April 4, 2025)
  • K242969 — Pantera Pro; Pantera LEO (October 25, 2024)
  • K240787 — Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitte (September 12, 2024)
  • K241711 — Oscar Peripheral Multifunctional Catheter system (July 11, 2024)
  • K230375 — BIOMONITOR IV (May 19, 2023)
  • K222065 — Passeo-35 Xeo Peripheral Dilatation Catheter (February 16, 2023)
  • K221856 — BIOMONITOR IIIm, BIOMONITOR III (July 27, 2022)
  • K222037 — Selectra Lead Implantation System (July 19, 2022)
  • K214038 — Oscar Peripheral Multifunctional Catheter system (July 6, 2022)
  • K201445 — MultiCath, AcQRate Dx Fixed Curve Catheter (September 2, 2021)

Other clearances for product code DTA

  • K163008 — CareLink SmartSync Device Manager - Pacing System Analyzer (February 28, 2017)
  • 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)
  • 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)