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510(k) K961992

NEEDLE'S EYE SNARE by Cook Pacemaker Corp. — Product Code DXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1996
Date Received
May 21, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Embolectomy
Device Class
Class II
Regulation Number
870.5150
Review Panel
CV
Submission Type

Other clearances by Cook Pacemaker Corp.

  • K970690 — LOCKING STYLET 2 (May 20, 1997)
  • 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)
  • K854132 — COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS (December 3, 1985)

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  • K193379 — Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe (June 12, 2020)
  • K163031 — Bunegin-Albin Air Aspiration Set (July 27, 2017)
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