FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CATHETER INSERTION TRAY
K Number: K962849
·
Decision Oct 7, 1996
Classifications
1
FEI Numbers
89
Registration Numbers
89
Same Product Code
297
Applicant Total
8
Review Days
77
Basic Information
- Device Name
- CATHETER INSERTION TRAY
- K Number
- K962849
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDCARE MEDICAL GROUP, INC.
- Date Received
- July 22, 1996
- Decision Date
- October 7, 1996
- 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 MEDCARE MEDICAL GROUP, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K973497 | HUBERLOC | Jan 13, 1998 | Substantially Equivalent |
| K970152 | BIOPSY TRAY | Mar 5, 1997 | Substantially Equivalent for Some Indications |
| K961075 | MEDCARE REGIONAL ANETHESIA KIT | Sep 6, 1996 | Unknown |
| K962328 | SINGLE USE INSTRUMENT TRAY | Aug 9, 1996 | Substantially Equivalent |
| K962527 | GENERAL PURPOSE DENTAL TRAY | Aug 1, 1996 | Substantially Equivalent |
| K961880 | MEDCARE SUCTION CONNECTING TUBING | Jul 19, 1996 | Substantially Equivalent |
| K961167 | MEDCARE TRACHEOSTOMY CARE TRAY | Jul 2, 1996 | Unknown |