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510(k) K760513

ELECTRODE, TEMPORARY MYOCARDIAL by Winn Hirsch & Assoc. — Product Code DTB

K760513 is an FDA 510(k) premarket notification submitted by Winn Hirsch & Assoc. for the device "ELECTRODE, TEMPORARY MYOCARDIAL". The FDA issued a decision of Substantially Equivalent on October 15, 1976. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Winn Hirsch & Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1976
Date Received
August 25, 1976
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 Winn Hirsch & Assoc.

  • K880309 — TYPE 316L STAINLESS STEEL WIRE (February 29, 1988)
  • K864375 — TYPE 316L COTTER WIRE (May 20, 1987)
  • K832214 — GAUZE CONVERSION CLASS I-NON-STERILE (July 26, 1983)
  • K832213 — GAUZE CONVERSION CLASS II STERILE (July 26, 1983)
  • K830511 — ZANLEX, ZAN-TEX & ZANDEX (March 17, 1983)
  • K812390 — NEUROSPONGE PADDIE (November 24, 1981)
  • K812391 — NEUROSPONGES (November 24, 1981)
  • K800195 — COTTON UNDER CAST PADDING (February 11, 1980)
  • K761155 — CELLULOSE EYE STICK (December 16, 1976)
  • K760365 — BLANKET, BURN (August 11, 1976)

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