FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATO FIRST PICC-DUAL LUMEN
K Number: K944685
·
Decision Mar 31, 1995
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
301
Applicant Total
12
Review Days
190
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Basic Information
- Device Name
- CATO FIRST PICC-DUAL LUMEN
- K Number
- K944685
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Catco Medical, Inc.
- Date Received
- September 22, 1994
- Decision Date
- March 31, 1995
- Product Code
- LJS
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | FDA class 2 | General Hospital |
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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 |
| 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 |
| K945727 | CATCO NEONATAL PALATE GUARD | Dec 7, 1994 | Substantially Equivalent |