FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VERSA-VIAL
K Number: K920177
·
Decision Jul 13, 1992
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
2
Applicant Total
10
Review Days
181
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VERSA-VIAL
- K Number
- K920177
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1670
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioteque America, Inc.
- Date Received
- January 14, 1992
- Decision Date
- July 13, 1992
- Product Code
- DQF
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DQF | Actuator, Syringe, Injector Type | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQF), ordered by most recent decision date.
ALCON FLUID INJECTOR
FDA 510(k)
FDA Class 2
·Cardiovascular
MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Bioteque America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K041094 | HSG CATHETER SET | Jun 17, 2004 | Substantially Equivalent |
| K020628 | CURELLE, PREFERRED CURELLE, CUTEQ 2.5 | May 24, 2002 | Substantially Equivalent |
| K013289 | BIOTEQUE VAGINAL PESSARIES | Dec 27, 2001 | Substantially Equivalent |
| K003380 | BIOTEQUE VAGINAL DILATOR | Jan 29, 2001 | Substantially Equivalent |
| K920633 | PESSARY FLEXIBLE SILICONE NICHOLS | Nov 8, 1995 | Substantially Equivalent |
| K920747 | PESSARY FLEXIBLE SILICONE DONUT RING | Aug 29, 1994 | Substantially Equivalent |
| K933628 | CYTOLOGY BRUSH | Mar 11, 1994 | Substantially Equivalent |
| K933521 | SPECULUM | Mar 7, 1994 | Substantially Equivalent |
| K920187 | FLEXIBLE SILICONE GELIHORN | Oct 23, 1992 | Substantially Equivalent |