FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
VENOUS CANNULA TRAY
K Number: K813284
·
Decision Dec 29, 1981
Classifications
1
FEI Numbers
313
Registration Numbers
313
Same Product Code
70
Applicant Total
10
Review Days
36
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Basic Information
- Device Name
- VENOUS CANNULA TRAY
- K Number
- K813284
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 870.4500
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Cunningham Woodland, Inc.
- Date Received
- November 23, 1981
- Decision Date
- December 29, 1981
- Product Code
- DWS
- 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 |
|---|---|---|---|
| DWS | Instruments, Surgical, Cardiovascular | FDA class 1 | Cardiovascular |
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Other Clearances by Cunningham Woodland, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K823527 | SUBCLAVIAN INSERTION KIT | Mar 31, 1983 | Substantially Equivalent |
| K813286 | PRE-PACK TENS | Jan 22, 1982 | Substantially Equivalent |
| K813519 | NON-ABSORBENT TOWELS | Jan 5, 1982 | Substantially Equivalent |
| K811090 | MAJOR DRESSING TRAY | May 8, 1981 | Substantially Equivalent |
| K811091 | MINOR DRESSING TRAY | May 8, 1981 | Substantially Equivalent |
| K811089 | ONE STEP PREP KIT | May 8, 1981 | Substantially Equivalent |
| K811088 | DRESSING TRAY MERCY HOSPITAL | May 8, 1981 | Substantially Equivalent |
| K811086 | SUTURE REMOVAL SET(DISPLSABLE) | May 1, 1981 | Substantially Equivalent |
| K811087 | MIKA SKIN SCRUB TRAY PRE OPERATIVE W/GEL | May 1, 1981 | Substantially Equivalent |