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510(k) K905403

MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER by Cook Pacemaker Corp. — Product Code DXY

K905403 is an FDA 510(k) premarket notification submitted by Cook Pacemaker Corp. for the device "MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER". The FDA issued a decision of Substantially Equivalent on October 16, 1991. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Cook Pacemaker Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1991
Date Received
December 3, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implantable Pacemaker Pulse-Generator
Device Class
Class III
Regulation Number
870.3610
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)
  • K915188 — MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD (September 11, 1992)
  • 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 DXY

  • K993434 — PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A (November 10, 1999)
  • K970072 — OPUS S MODEL 4121 AND 4124 PACEMAKERS (August 29, 1997)
  • K945627 — PIKOS LP 01, PIKOS LP E01 (March 4, 1996)
  • K954092 — ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) (December 15, 1995)
  • K953866 — MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) (December 15, 1995)
  • K952328 — NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 (September 29, 1995)
  • K953417 — MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS (September 29, 1995)
  • K952364 — OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) (September 1, 1995)
  • K940039 — PELLETHANE 75D (July 12, 1995)
  • K946188 — CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER (May 15, 1995)

FDA data resources