FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
K Number: K953394
·
Decision Oct 12, 1995
Classifications
1
FEI Numbers
37
Registration Numbers
38
Same Product Code
48
Applicant Total
49
Review Days
87
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
- VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}
- K Number
- K953394
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Visitec Co.
- Date Received
- July 17, 1995
- Decision Date
- October 12, 1995
- Product Code
- LZU
- Advisory Committee
- Unknown
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| LZU | Plug, Punctum | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LZU), ordered by most recent decision date.
Hello,eyes® BIO Plug
FDA 510(k)
FDA Unclassified
·Unknown
Visant Medical Canalicular Plug
FDA 510(k)
FDA Unclassified
·Unknown
SOFT PLUG Extended Duration 180 Tapered Canalicular Plug
FDA 510(k)
FDA Unclassified
·Unknown
Tear Pool Dissolvable Punctum Plugs
FDA 510(k)
FDA Unclassified
·Unknown
Soft Plug Extended Duration 180 Canalicular Plug
FDA 510(k)
FDA Unclassified
·Unknown
LacriPro Punctum Plug
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Visitec Co.
| K Number | Device Name | ||
|---|---|---|---|
| K945114 | VISITEC SCLERAL PLUG | Feb 23, 1995 | Substantially Equivalent |
| K945738 | VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE | Feb 14, 1995 | Substantially Equivalent |
| K945172 | VISITEC SILICONE RETINAL IMPLANTS/EXPLANTS | Jan 17, 1995 | Substantially Equivalent |
| K942234 | VISITEC PRECISE-POINT | Jul 12, 1994 | Substantially Equivalent |
| K934269 | FIBEROPTIC ILLUMINATED INSTRUMENTS | May 17, 1994 | Substantially Equivalent |
| K940210 | VISITEC EYE PAD | Mar 7, 1994 | Substantially Equivalent |
| K933872 | VISI-SPEAR EYE SPONGE | Dec 27, 1993 | Substantially Equivalent |
| K923972 | OPHTHALMIC FLUID DISTRIBUTION SETS | Nov 4, 1992 | Substantially Equivalent |
| K922530 | VISITEC MICROSURGICAL SUTURE | Oct 20, 1992 | Substantially Equivalent |
| K923645 | VISITEC ASPIRATING SYRINGE | Sep 30, 1992 | Substantially Equivalent |