FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017
K Number: K991059
·
Decision Nov 16, 1999
Classifications
1
FEI Numbers
271
Registration Numbers
272
Same Product Code
880
Applicant Total
24
Review Days
231
Basic Information
- Device Name
- SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017
- K Number
- K991059
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SPECTRANETICS CORP.
- Date Received
- March 30, 1999
- Decision Date
- November 16, 1999
- 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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