FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492
K Number: K944966
·
Decision Jul 14, 1995
Classifications
1
FEI Numbers
69
Registration Numbers
69
Same Product Code
128
Applicant Total
15
Review Days
276
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Basic Information
- Device Name
- UNIPOLAR ATRIAL TEMPORARY PACING LEAD,MODEL 6492
- K Number
- K944966
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.3680
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Blood Systems, Inc.
- Date Received
- October 11, 1994
- Decision Date
- July 14, 1995
- Product Code
- LDF
- 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 |
|---|---|---|---|
| LDF | Electrode, Pacemaker, Temporary | FDA class 2 | Cardiovascular |
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Other Clearances by Medtronic Blood Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K944957 | TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 | Jul 14, 1995 | Substantially Equivalent |
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| K891687 | EXTRACORPOREAL CIRCUIT WITH BIO-ACTIVE SURFACE | May 31, 1989 | Substantially Equivalent |
| K891230 | MAXIMA* HOLLOW FIBER OXYGENATOR W/FILTERED RESERV. | May 19, 1989 | Substantially Equivalent |
| K885154 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA DELIV. SYSTEM | Feb 22, 1989 | Substantially Equivalent |
| K884390 | INTERSEPT* CRYSTALLOID CARDIOPLEGIA FILTER | Dec 21, 1988 | Substantially Equivalent |
| K884244 | INTERSEPT* PREBYPASS FILTER | Dec 5, 1988 | Substantially Equivalent |
| K883439 | INTERSEPT*CRYSTALLOID CARDIOPLEGIA DELIVERY SYSTEM | Oct 13, 1988 | Substantially Equivalent |
| K883086 | INTERSEPT*PREBYPASS FILTER | Sep 16, 1988 | Substantially Equivalent |