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510(k) K915188

MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD by Cook Pacemaker Corp. — Product Code DTB

K915188 is an FDA 510(k) premarket notification submitted by Cook Pacemaker Corp. for the device "MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD". The FDA issued a decision of SESP on September 11, 1992. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Cook Pacemaker Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESP ()
Decision Date
September 11, 1992
Date Received
November 18, 1991
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 Cook Pacemaker Corp.

  • K970690 — LOCKING STYLET 2 (May 20, 1997)
  • K961992 — NEEDLE'S EYE SNARE (December 27, 1996)
  • K953417 — MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS (September 29, 1995)
  • K905403 — MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER (October 16, 1991)
  • K863582 — MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) (October 8, 1986)
  • K861559 — SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS (May 9, 1986)
  • K860202 — MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER. (February 24, 1986)
  • K860466 — MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. (February 24, 1986)
  • K854919 — BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY (December 19, 1985)
  • K854132 — COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS (December 3, 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