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510(k) K890895

IMPLANTABLE ADAPTOR 033-380 by Telectronics, Inc. — Product Code DTD

K890895 is an FDA 510(k) premarket notification submitted by Telectronics, Inc. for the device "IMPLANTABLE ADAPTOR 033-380". The FDA issued a decision of Substantially Equivalent on March 6, 1990. The device falls under product code DTD (Pacemaker Lead Adaptor), a Class II device regulated under 21 CFR 870.3620. Telectronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1990
Date Received
February 22, 1989
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 Telectronics, Inc.

  • K891231 — OPTIMA MPT AND SPT PACEMAKERS (September 12, 1989)
  • K890350 — VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) (February 2, 1989)
  • K884411 — OPTIMA MPT AND SPT PACEMAKERS (January 26, 1989)
  • K884278 — IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 (December 15, 1988)
  • K881837 — OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D (July 18, 1988)
  • K874664 — IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 (May 31, 1988)
  • K864712 — MODEL 1740 PERSONAL POCKET PROGRAMMER (December 17, 1987)
  • K872766 — IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS (November 4, 1987)
  • K865098 — SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438 (August 18, 1987)
  • K871992 — IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS (August 12, 1987)

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)
  • K971930 — BK-N SEALING CAP (August 14, 1997)

FDA data resources