FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
KENDALL SAFETRAK(TM) HIGH FLOW CATHETER
K Number: K903732
·
Decision Oct 3, 1990
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
66
Review Days
48
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Basic Information
- Device Name
- KENDALL SAFETRAK(TM) HIGH FLOW CATHETER
- K Number
- K903732
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Applicant
- Kendall Healthcare Products Co. Div.Of Tyco Health
- Date Received
- August 16, 1990
- Decision Date
- October 3, 1990
- 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 Kendall Healthcare Products Co. Div.Of Tyco Health
| K Number | Device Name | ||
|---|---|---|---|
| K973763 | KENDALL CURITY IODOFORM PACKING STRIP | Dec 31, 1997 | Substantially Equivalent |
| K973511 | KENDALL CURITY PETROLATUM GAUZE | Dec 16, 1997 | Substantially Equivalent for Some Indications |
| K973507 | KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317) | Dec 15, 1997 | Substantially Equivalent for Some Indications |
| K973619 | KENDALL CURITY NON-ADHERING DRESSING | Dec 10, 1997 | Substantially Equivalent for Some Indications |
| K973509 | KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING | Dec 4, 1997 | Substantially Equivalent for Some Indications |
| K973546 | KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER | Nov 7, 1997 | Substantially Equivalent |
| K970266 | KENDALL HYDROPHILIC POWDER WOUND DRESSING | Apr 23, 1997 | Substantially Equivalent for Some Indications |
| K963446 | KENDALL DUAL LUMEN CATHETER | Mar 18, 1997 | Substantially Equivalent |
| K964899 | KENDALL CURITY URETERAL CATHETER | Feb 7, 1997 | Substantially Equivalent |
| K964519 | CURITY THORACENTESIS TRAY | Dec 20, 1996 | Substantially Equivalent |