FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SUCTION CATHETER KIT
K Number: K863497
·
Decision Oct 6, 1986
Classifications
1
FEI Numbers
245
Registration Numbers
245
Same Product Code
115
Applicant Total
7
Review Days
27
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Basic Information
- Device Name
- SUCTION CATHETER KIT
- K Number
- K863497
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6810
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Welmed Systems, Inc.
- Date Received
- September 9, 1986
- Decision Date
- October 6, 1986
- Product Code
- BSY
- 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 |
|---|---|---|---|
| BSY | Catheters, Suction, Tracheobronchial | FDA class 1 | Anesthesiology |
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Other Clearances by Welmed Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K863282 | CARE + PLUS CATHETER CARE TRAY | Oct 31, 1986 | Substantially Equivalent |
| K863281 | CARE + PLUS IRREGATION TRAY | Oct 31, 1986 | Substantially Equivalent |
| K863284 | I.V. START KIT | Sep 22, 1986 | Unknown |
| K863283 | CARE + PLUS SUTURE REMOVAL TRAY | Sep 15, 1986 | Substantially Equivalent |
| K862663 | TRACHEOSTOMY CARE TRAY | Jul 30, 1986 | Substantially Equivalent |
| K862219 | T.P.N. DRESSING CHANGE TRAY | Jul 8, 1986 | Unknown |