FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PROMED BIOPSY NEEDLE
K Number: K933364
·
Decision Feb 15, 1994
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
10
Applicant Total
12
Review Days
221
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Basic Information
- Device Name
- PROMED BIOPSY NEEDLE
- K Number
- K933364
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4800
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vlv Associates, Inc.
- Date Received
- July 9, 1993
- Decision Date
- February 15, 1994
- Product Code
- DWO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| DWO | Needle, Biopsy, Cardiovascular | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
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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. |
| 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 |
| K901081 | PRO-LOCK(TM) SHIELDING NEEDLE CONNECTOR ASSEMBLY | Jun 8, 1990 | Substantially Equivalent |