FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CATCO NEONATAL PALATE GUARD
K Number: K945727
·
Decision Dec 7, 1994
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
2
Applicant Total
12
Review Days
15
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Basic Information
- Device Name
- CATCO NEONATAL PALATE GUARD
- K Number
- K945727
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5820
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Catco Medical, Inc.
- Date Received
- November 22, 1994
- Decision Date
- December 7, 1994
- Product Code
- BRW
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BRW | Protector, Dental | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BRW), ordered by most recent decision date.
WILEY/ESPOSITO DENTAL GUARD
FDA 510(k)
FDA Class 1
·Anesthesiology
TIP TOLEDO INCISOR PROTECTOR
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Catco Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K945728 | CATCO THORACIC CATHETER | May 23, 1995 | Substantially Equivalent |
| K944368 | CATCO SILICONE UMBILICAL VESSEL CATHETER | Apr 5, 1995 | Substantially Equivalent |
| K944367 | CATCO POLYURETHANE UMBILICAL VESSEL CATHETER | Apr 5, 1995 | Substantially Equivalent |
| K944336 | CATCO UMBILICAL VESSEL CATHETER | Apr 5, 1995 | Substantially Equivalent |
| K944410 | CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER | Apr 5, 1995 | Substantially Equivalent |
| K944685 | CATO FIRST PICC-DUAL LUMEN | Mar 31, 1995 | Substantially Equivalent |
| K944504 | CATCO FIRST PICC | Mar 31, 1995 | Substantially Equivalent |
| K945012 | CATCO NUTRITIONAL CATHETER | Feb 24, 1995 | Substantially Equivalent |
| K945258 | CATCO URINARY COLLECTION KIT | Feb 16, 1995 | Unknown |
| K945499 | CATO FIRST PICC KIT | Feb 7, 1995 | Substantially Equivalent |