FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ERYTHROCATH INTRAVENOUS CATHETER PLA. U.
K Number: K801414
·
Decision Aug 13, 1980
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
56
Review Days
58
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Basic Information
- Device Name
- ERYTHROCATH INTRAVENOUS CATHETER PLA. U.
- K Number
- K801414
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- G.D. Searle and Co.
- Date Received
- June 16, 1980
- Decision Date
- August 13, 1980
- Product Code
- FOZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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Other Clearances by G.D. Searle and Co.
| K Number | Device Name | ||
|---|---|---|---|
| K821159 | IN-LINE OXYGEN MONITORING SYSTEM | May 25, 1982 | Substantially Equivalent |
| K811068 | BYPASS COIL | May 27, 1981 | Substantially Equivalent |
| K811071 | VENOUS OXYGEN PROBE | May 5, 1981 | Substantially Equivalent |
| K803238 | INTRAVASCULAR CATHETER | Apr 23, 1981 | Substantially Equivalent |
| K810630 | SILICONE ELASTOMER COATED LATEX FOLEY | Mar 31, 1981 | Substantially Equivalent |
| K810131 | ADMINISTRATION SET | Feb 26, 1981 | Substantially Equivalent |
| K802485 | SEARLE VASCULAR LOOPS | Feb 12, 1981 | Substantially Equivalent |
| K801805 | METRONIDAZOLE DISCS | Feb 10, 1981 | Substantially Equivalent |
| K810112 | SWR DISPOSABLE PREP RAZOR | Feb 4, 1981 | Substantially Equivalent |
| K802213 | WHITE KNIGHT BOVIE CORD/SUCTION TUBE | Oct 10, 1980 | Substantially Equivalent |