FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANSFER SET
K Number: K935532
·
Decision Apr 4, 1994
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
205
Applicant Total
24
Review Days
139
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Basic Information
- Device Name
- TRANSFER SET
- K Number
- K935532
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Puritas Health Care, Inc.
- Date Received
- November 16, 1993
- Decision Date
- April 4, 1994
- Product Code
- LHI
- 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 |
|---|---|---|---|
| LHI | Set, I.V. Fluid Transfer | FDA class 2 | General Hospital |
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Other Clearances by Puritas Health Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K942339 | SKIN NEUVEAU SCAR TREATMENT | Nov 28, 1994 | Substantially Equivalent |
| K941197 | SILK*SKIN SCAR TREATMENT | Aug 11, 1994 | Substantially Equivalent |
| K935600 | TRACHEAL SUCTION CATHETER | May 10, 1994 | Unknown |
| K935531 | OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP | May 5, 1994 | Substantially Equivalent |
| K940074 | Y-TYPE BLOOD ADMINISTRATION SET | Apr 21, 1994 | Substantially Equivalent |
| K940055 | MULTISET | Apr 15, 1994 | Substantially Equivalent |
| K940054 | MEASURED VOLUME SOLUTION ADMINISTRATION SET | Apr 15, 1994 | Substantially Equivalent |
| K935583 | SUCTION SET, TRACHAEL | Apr 11, 1994 | Unknown |
| K940056 | WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM | Apr 4, 1994 | Substantially Equivalent |
| K940070 | STOPCOCK INTRAVENOUS THERAPY | Apr 4, 1994 | Substantially Equivalent |