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510(k) K972814

LOCATOR MODEL 4036 by Pacesetter, Inc. — Product Code DTB

K972814 is an FDA 510(k) premarket notification submitted by Pacesetter, Inc. for the device "LOCATOR MODEL 4036". The FDA issued a decision of ST on February 23, 1998. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Pacesetter, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
ST ()
Decision Date
February 23, 1998
Date Received
July 29, 1997
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 Pacesetter, Inc.

  • K960854 — SIEMENS SERVO ULTRA NEBULIZER 345 (December 23, 1996)
  • K954714 — AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION) (February 1, 1996)
  • K954551 — DF-1 TERMINAL CAP (December 26, 1995)
  • K952206 — PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING (August 31, 1995)
  • K951950 — PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING (August 31, 1995)
  • K951087 — TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD (June 29, 1995)
  • K950140 — IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 (April 6, 1995)

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