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510(k) K890350

VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) by Telectronics, Inc. — Product Code DTB

K890350 is an FDA 510(k) premarket notification submitted by Telectronics, Inc. for the device "VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)". The FDA issued a decision of Substantially Equivalent on February 2, 1989. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Telectronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1989
Date Received
November 8, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Permanent Pacemaker Electrode
Device Class
Class III
Regulation Number
870.3680
Review Panel
CV
Submission Type

Other clearances by Telectronics, Inc.

  • K890895 — IMPLANTABLE ADAPTOR 033-380 (March 6, 1990)
  • K891231 — OPTIMA MPT AND SPT PACEMAKERS (September 12, 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 DTB

  • K061212 — BIOTRONIK ENDOCARDIAL PACING LEADS (July 10, 2006)
  • K041809 — PERMANENT PACING LEAD, MODEL PY2 (August 6, 2004)
  • K040569 — PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU (April 7, 2004)
  • K031274 — MODEL 5071 MYOCARDIAL PACING LEAD (May 22, 2003)
  • K031210 — MODEL 4951M MYOCARDIAL UNIPOLAR LEAD (May 16, 2003)
  • K023205 — ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP (April 24, 2003)
  • K024053 — PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB (January 31, 2003)
  • K023803 — MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS (December 11, 2002)
  • K023099 — AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP (October 18, 2002)
  • K021217 — AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP (May 1, 2002)

FDA data resources