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510(k) K770416

LEAD, HEART, BUTTERFLY CLAMP by Arco Medical Products Co. — Product Code DTB

K770416 is an FDA 510(k) premarket notification submitted by Arco Medical Products Co. for the device "LEAD, HEART, BUTTERFLY CLAMP". The FDA issued a decision of Substantially Equivalent on March 10, 1977. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Arco Medical Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1977
Date Received
March 4, 1977
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 Arco Medical Products Co.

  • K802588 — MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. (November 19, 1980)
  • K801806 — EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE (September 9, 1980)
  • K800837 — PROGRAMMABLE BIPOLAR CARDIAC GENERATOR (June 30, 1980)
  • K801241 — UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. (June 30, 1980)
  • K800838 — ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. (June 4, 1980)
  • K800326 — ARCOLITH 3021-CARDIAC PULSE GENERATOR (March 17, 1980)
  • K792216 — ARCOLITH 2100-CARDIAC PULSE GENERATOR (November 29, 1979)
  • K792299 — ARCOLITH 3020-CARDIAC PULSE GENERATOR (November 29, 1979)
  • K791715 — ARCOLITH 2000 (September 27, 1979)
  • K791147 — ARCO PROGAMMABLE PACEMAKER SYSTEM (August 3, 1979)

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