FDA 510(k)
FDA class 3
Substantially Equivalent - Subject to Tracking Reg.
🇺🇸 United States
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
K Number: K953417
·
Decision Sep 29, 1995
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
34
Review Days
113
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Basic Information
- Device Name
- MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
- K Number
- K953417
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent - Subject to Tracking Reg.
- Applicant
- Cook Pacemaker Corp.
- Date Received
- June 8, 1995
- Decision Date
- September 29, 1995
- Product Code
- DXY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | FDA class 3 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXY), ordered by most recent decision date.
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
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MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
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NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
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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 |
| 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 |
| K854132 | COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS | Dec 3, 1985 | Substantially Equivalent |