FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CATHETER, NASAL, OXYGEN
K Number: K902420
·
Decision Apr 17, 1991
Classifications
1
FEI Numbers
263
Registration Numbers
263
Same Product Code
41
Applicant Total
13
Review Days
321
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Basic Information
- Device Name
- CATHETER, NASAL, OXYGEN
- K Number
- K902420
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5340
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Gainor Medical Europe, Ltd.
- Date Received
- May 31, 1990
- Decision Date
- April 17, 1991
- Product Code
- CAT
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAT | Cannula, Nasal, Oxygen | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CAT), ordered by most recent decision date.
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NASAL OXYGEN CANNULA, 81585, 81587 & 81589
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Gainor Medical Europe, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K926448 | I.V. ADMINISTRATION SET | May 2, 1994 | Substantially Equivalent |
| K931828 | CARELET SAFETY LANCET | Oct 15, 1993 | Substantially Equivalent |
| K931827 | CLEANLET, CLEANLET XL & KIDS | Sep 13, 1993 | Substantially Equivalent |
| K922441 | SURESEAL BANDAGE | Aug 10, 1993 | Substantially Equivalent |
| K913333 | I.V. PRIMING SET | Oct 23, 1991 | Substantially Equivalent |
| K902422 | NEEDLE, ASPIRATION & INJECTION, DISPOSABLE | Jun 6, 1991 | Substantially Equivalent |
| K902564 | NEEDLE, DIALYSIS | Mar 1, 1991 | Substantially Equivalent |
| K902426 | HEMODIALYSIS SYSTEM AND ACCESSORY | Nov 20, 1990 | Substantially Equivalent |
| K902421 | STOMACH, GASTRO-ENTEROSTOMY | Nov 20, 1990 | Substantially Equivalent |
| K902416 | SURELITE AND SURELITE XL BLOOD LANCET | Aug 1, 1990 | Substantially Equivalent |