FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DATASCOPE SLIDEWIRE(TM)
K Number: K901347
·
Decision Jun 21, 1990
Classifications
1
FEI Numbers
252
Registration Numbers
253
Same Product Code
751
Applicant Total
132
Review Days
90
Basic Information
- Device Name
- DATASCOPE SLIDEWIRE(TM)
- K Number
- K901347
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- DATASCOPE CORP.
- Date Received
- March 23, 1990
- Decision Date
- June 21, 1990
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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