Home / 510(k) Clearances / K921318

510(k) K921318

ADAPTING SLEEVE KIT MODEL 4023 by Siemens-Pacesetter, Inc. — Product Code DTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1992
Date Received
March 19, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pacemaker Lead Adaptor
Device Class
Class II
Regulation Number
870.3620
Review Panel
CV
Submission Type

Other clearances by Siemens-Pacesetter, Inc.

  • K942440 — AFP CARDIAC PACING SYSTEM MODEL 283 (August 8, 1994)
  • K925038 — PACING LEAD MODEL 1188T (July 15, 1994)
  • K932892 — PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS (July 6, 1994)
  • K930876 — SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T (June 15, 1994)
  • K925347 — MODEL 1148T TRANSVENOUS, SCREW-IN LEAD (June 10, 1993)
  • K920822 — CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE (January 22, 1993)

Other clearances for product code DTD

  • K143463 — IS4/DF4 Port Plug (March 19, 2015)
  • K132008 — 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866- (July 30, 2013)
  • K041574 — CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 (July 12, 2004)
  • K031164 — PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV (June 19, 2003)
  • K024156 — PACING LEAD EXTENSIONS, BIPOLAR, PACING LEAD ADAPTORS, UNIPOLAR/BIPOLAR,PACING L (January 14, 2003)
  • K010787 — PACING LEAD BIPOLAR ADAPTERS AND EXTENSIONS (May 22, 2001)
  • K003454 — A1-CS-SB Y-ADAPTER, MODEL 124 871 (January 18, 2001)
  • K000210 — MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT (February 23, 2000)
  • K982220 — MODEL 2872 BIPOLAR LEAD ADAPTOR KIT (October 15, 1998)
  • K970388 — A1-A,ABP,B,MBP, LEAD CONNECTORS; PEH ADAPTER SLEEVE (August 14, 1997)