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510(k) K843001

COOK PACEMAKER CORP. 116 BIOPOLAR CARDI by Cook Pacemaker Corp.

K843001 is an FDA 510(k) premarket notification submitted by Cook Pacemaker Corp. for the device "COOK PACEMAKER CORP. 116 BIOPOLAR CARDI". The FDA issued a decision of SESP on July 30, 1984. Cook Pacemaker Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESP ()
Decision Date
July 30, 1984
Date Received
July 30, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K915188 — MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD (September 11, 1992)
  • 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)

FDA data resources