FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATCO NUTRITIONAL CATHETER
K Number: K945012
·
Decision Feb 24, 1995
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
12
Review Days
134
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Basic Information
- Device Name
- CATCO NUTRITIONAL CATHETER
- K Number
- K945012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Catco Medical, Inc.
- Date Received
- October 13, 1994
- Decision Date
- February 24, 1995
- Product Code
- KNT
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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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 |
| K945258 | CATCO URINARY COLLECTION KIT | Feb 16, 1995 | Unknown |
| K945499 | CATO FIRST PICC KIT | Feb 7, 1995 | Substantially Equivalent |
| K945727 | CATCO NEONATAL PALATE GUARD | Dec 7, 1994 | Substantially Equivalent |