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510(k) K850065

ELECATH TORKFLOAT PACING PROBE by Electro-Catheter Corp. — Product Code DTB

K850065 is an FDA 510(k) premarket notification submitted by Electro-Catheter Corp. for the device "ELECATH TORKFLOAT PACING PROBE". The FDA issued a decision of Substantially Equivalent on April 10, 1985. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Electro-Catheter Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1985
Date Received
January 8, 1985
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 Electro-Catheter Corp.

  • K934785 — MULTIPACE (July 27, 1995)
  • K943257 — TIP DEFLECTOR (GENESIS) (April 19, 1995)
  • K933450 — CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION (April 19, 1995)
  • K933451 — OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION (April 19, 1995)
  • K934787 — SILICORE SEMI-FLOATER (February 24, 1995)
  • K874154 — ELECATH(R) TRANSESOPHAGEAL PACING CATHETER (April 29, 1988)
  • K854511 — ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET (February 10, 1986)
  • K854975 — ELECATH PULSATILE PERFUSION PUMP (January 15, 1986)
  • K850324 — ELECATH OPEN TIP BIPOLAR PACING CATHETER (March 27, 1985)
  • K844682 — ELECATH CARDIAC OUTPUT COMPUTER (March 6, 1985)

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