FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORDIS PTCA GUIDING CATHETER, MODIFICATION
K Number: K913783
·
Decision Oct 18, 1991
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
74
Review Days
65
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Basic Information
- Device Name
- CORDIS PTCA GUIDING CATHETER, MODIFICATION
- K Number
- K913783
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Dow Corning Wright
- Date Received
- August 14, 1991
- Decision Date
- October 18, 1991
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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| K930188 | ORTHOLOC(R) ADVANTIM(TM) FEMORAL COMPONENT | Aug 3, 1993 | Substantially Equivalent |
| K930190 | ORTHOLOC(R) ADVANTIM(TM) NON-POR COAT FEMOR COMP | Aug 2, 1993 | Substantially Equivalent |