FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI
K Number: K853590
·
Decision Oct 23, 1985
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
460
Applicant Total
34
Review Days
56
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Basic Information
- Device Name
- COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI
- K Number
- K853590
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cook Pacemaker Corp.
- Date Received
- August 28, 1985
- Decision Date
- October 23, 1985
- 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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FDA Class 3
·Cardiovascular
OPUS S MODEL 4121 AND 4124 PACEMAKERS
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FDA Class 3
·Cardiovascular
PIKOS LP 01, PIKOS LP E01
FDA 510(k)
FDA Class 3
·Cardiovascular
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
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FDA Class 3
·Cardiovascular
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
FDA 510(k)
FDA Class 3
·Cardiovascular
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
FDA 510(k)
FDA Class 3
·Cardiovascular
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 |