FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIBEROPTIC CATHETER
K Number: K880661
·
Decision May 2, 1988
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
15
Review Days
75
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Basic Information
- Device Name
- FIBEROPTIC CATHETER
- K Number
- K880661
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Optimed Technologies, Inc.
- Date Received
- February 17, 1988
- Decision Date
- May 2, 1988
- Product Code
- DQO
- 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
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Other Clearances by Optimed Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972520 | OPTIVIEW | Sep 29, 1997 | Substantially Equivalent |
| K955275 | BOOSTER TROPHY 5 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K955276 | BOOSTER LITE 4 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K955274 | BOOSTER LITE 3 MOTORIZED SCOOTER | Nov 4, 1996 | Substantially Equivalent |
| K943598 | FLEXIBLE FIBER OPTIC LAPAROSCOPES | Oct 18, 1994 | Substantially Equivalent |
| K926597 | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) | Jul 12, 1994 | Substantially Equivalent |
| K921942 | HYSTEROSCOPE (AND ACCESSORIES) | Jun 24, 1994 | Substantially Equivalent |
| K922711 | FLEXIBLE FIBER OPTIC GYNECOLOGIC ENDOSCOPE | May 17, 1994 | Substantially Equivalent |
| K921985 | ARTHROSCOPE & ACCESSORIES | Jun 29, 1993 | Substantially Equivalent |
| K922826 | FLEXIBLE FIBER OPTIC ENDOSCOPE | Feb 19, 1993 | Substantially Equivalent |