FDA 510(k)
Unknown
🇺🇸 United States
COOK PACEMAKER CORP. 116 BIOPOLAR CARDI
K Number: K843001
·
Decision Jul 30, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
34
Review Days
—
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Basic Information
- Device Name
- COOK PACEMAKER CORP. 116 BIOPOLAR CARDI
- K Number
- K843001
- Clearance Type
- Traditional
- Decision
- Unknown
- Applicant
- Cook Pacemaker Corp.
- Date Received
- July 30, 1984
- Decision Date
- July 30, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Other Clearances by Cook Pacemaker Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K970690 | LOCKING STYLET 2 | May 20, 1997 | Substantially Equivalent |
| K961992 | NEEDLE'S EYE SNARE | Dec 27, 1996 | Substantially Equivalent |
| K953417 | MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS | Sep 29, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K915188 | MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD | Sep 11, 1992 | Unknown |
| K905403 | MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER | Oct 16, 1991 | Substantially Equivalent |
| K863582 | MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) | Oct 8, 1986 | Substantially Equivalent |
| K861559 | SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS | May 9, 1986 | Substantially Equivalent |
| K860202 | MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER. | Feb 24, 1986 | Substantially Equivalent |
| K860466 | MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. | Feb 24, 1986 | Substantially Equivalent |
| K854919 | BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY | Dec 19, 1985 | Substantially Equivalent |