FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KATZEN THROMBOLYSIS GUIDEWIRE
K Number: K883880
·
Decision Apr 6, 1989
Classifications
1
FEI Numbers
252
Registration Numbers
253
Same Product Code
751
Applicant Total
36
Review Days
205
Basic Information
- Device Name
- KATZEN THROMBOLYSIS GUIDEWIRE
- K Number
- K883880
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- MEDI-TECH, INC.
- Date Received
- September 13, 1988
- Decision Date
- April 6, 1989
- 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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| K922990 | HEMODIALYSIS BATH | Sep 12, 1994 | Substantially Equivalent |
| K942552 | THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED | Sep 9, 1994 | Substantially Equivalent |
| K904073 | COAGULATION REFERENCE PLASMA, ABNORMAL | Oct 22, 1990 | Substantially Equivalent |
| K895819 | MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL | Nov 2, 1989 | Substantially Equivalent for Some Indications |