FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PRESSURE INFUSION CUFF
K Number: K942933
·
Decision Aug 25, 1994
Classifications
1
FEI Numbers
83
Registration Numbers
83
Same Product Code
34
Applicant Total
9
Review Days
64
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Basic Information
- Device Name
- PRESSURE INFUSION CUFF
- K Number
- K942933
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.5420
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Circulatory Technology, Inc.
- Date Received
- June 22, 1994
- Decision Date
- August 25, 1994
- Product Code
- KZD
- 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 |
|---|---|---|---|
| KZD | Infusor, Pressure, For I.V. Bags | FDA class 1 | General Hospital |
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Other Clearances by Circulatory Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K140321 | INITARY BETTER BLADDER-PEDIATRIC | Apr 17, 2014 | Substantially Equivalent |
| K012942 | THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 | Nov 5, 2001 | Substantially Equivalent |
| K001822 | THE V-BAG | Jul 7, 2000 | Substantially Equivalent |
| K981284 | BETTER-BLADDER (BB) | Aug 12, 1998 | Substantially Equivalent |
| K964205 | BETTER-TUBING | Apr 8, 1998 | Substantially Equivalent |
| K964337 | BETTER-BLADDER (BB) | May 23, 1997 | Substantially Equivalent |
| K961594 | BETTER-VENTER | Sep 5, 1996 | Substantially Equivalent |
| K941492 | PRESSURE RELIEF VALVE | Oct 26, 1994 | Substantially Equivalent |