FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PRO-LOCK(TM) SHIELDING NEEDLE CONNECTOR ASSEMBLY
K Number: K901081
·
Decision Jun 8, 1990
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
12
Review Days
93
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Basic Information
- Device Name
- PRO-LOCK(TM) SHIELDING NEEDLE CONNECTOR ASSEMBLY
- K Number
- K901081
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Vlv Associates, Inc.
- Date Received
- March 7, 1990
- Decision Date
- June 8, 1990
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Vlv Associates, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972957 | SA-EF MULTI-LUMEN EXTENSION SET | Sep 29, 1997 | Substantially Equivalent |
| K964876 | SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET | Feb 28, 1997 | Substantially Equivalent |
| K955783 | VLV SA.EF INFUSION PORT EXTENSION SETS | Feb 7, 1996 | Substantially Equivalent |
| K953791 | VLV SA EF INFUSION PORT | Oct 30, 1995 | Substantially Equivalent |
| K945592 | VLV SOLODRAW(TM) DUAL CHAMBER PISTON SYRINGE | Jul 14, 1995 | Substantially Equivalent |
| K940406 | DISPOSABLE, AMBULATORY, INFUSION PUMPS | Sep 2, 1994 | Substantially Equivalent - Subject to Tracking Reg. |
| K933364 | PROMED BIOPSY NEEDLE | Feb 15, 1994 | Substantially Equivalent |
| K922469 | PRO-LOK EXTENSION SET(S) | Mar 15, 1993 | Substantially Equivalent |
| K904217 | PRO-LOK (TM) EXTENSION SETS | Oct 3, 1990 | Substantially Equivalent |
| K901046 | VERSA-LOCK(TM) UNIVERSAL NEEDLE CONNECTOR | Jun 8, 1990 | Substantially Equivalent |