FDA 510(k)
FDA class 3
Substantially Equivalent
🇺🇸 United States
PROGRAMMER, MEDTRONIC MODEL 5984/5985
K Number: K791181
·
Decision Sep 20, 1979
Classifications
1
FEI Numbers
28
Registration Numbers
28
Same Product Code
460
Applicant Total
468
Review Days
87
Basic Information
- Device Name
- PROGRAMMER, MEDTRONIC MODEL 5984/5985
- K Number
- K791181
- Device Class
- FDA class 3
- Clearance Type
- Traditional
- Regulation Number
- 870.3610
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- MEDTRONIC VASCULAR
- Date Received
- June 25, 1979
- Decision Date
- September 20, 1979
- 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 |
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Other Clearances by MEDTRONIC VASCULAR
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|---|---|---|---|
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| K133539 | TOTAL ACROSS | Mar 26, 2014 | Substantially Equivalent |
| K123990 | SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING | Apr 26, 2013 | Substantially Equivalent |
| K123358 | PACIFIC PLUS | Jan 29, 2013 | Substantially Equivalent |
| K101777 | PIONEER PLUS CATHETER, MODEL PLUS 120 | Jul 23, 2010 | Substantially Equivalent |
| K091582 | GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 | Dec 4, 2009 | Substantially Equivalent |
| K083422 | 6F TAIGA GUIDING CATHETER | Feb 6, 2009 | Substantially Equivalent |
| K082873 | MEDTRONIC ANGIOGRAPHIC GUIDE WIRES | Feb 6, 2009 | Substantially Equivalent |
| K081573 | MEDTRONIC EXPORT AP CATHETER | Jun 27, 2008 | Substantially Equivalent |