FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
A2 DETACHED DUAL PORT SYSTEM
K Number: K950212
·
Decision Apr 13, 1995
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
287
Applicant Total
26
Review Days
84
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Basic Information
- Device Name
- A2 DETACHED DUAL PORT SYSTEM
- K Number
- K950212
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Therex Corp.
- Date Received
- January 19, 1995
- Decision Date
- April 13, 1995
- Product Code
- LJT
- 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 |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | FDA class 2 | General Hospital |
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Other Clearances by Therex Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K953110 | LOW PROFILE TITANIUM MODEL CATALOG #1003 | Sep 13, 1995 | Substantially Equivalent |
| K953017 | LOW PROFILE TITANIUM MODEL CATALOG #1003 | Sep 8, 1995 | Substantially Equivalent |
| K952537 | THEREX LOW PROFILE TITANIUM MODEL 1.0MM I.D./1.8MM O.D. | Jul 6, 1995 | Substantially Equivalent |
| K950131 | 1.0MM 1.8MMO.D. POLYURETHANE DETACHED MODEL | Mar 23, 1995 | Substantially Equivalent |
| K942412 | THEREX LOW-PROFILE PORT - TITANIUM MODEL | Aug 19, 1994 | Substantially Equivalent |
| K934792 | THEREX LOW-PROFILE PORT | Mar 22, 1994 | Substantially Equivalent |
| K936012 | THEREX LOW PROFILE PORT-TITANIUM MODEL | Mar 22, 1994 | Substantially Equivalent |
| K934802 | THEREX LOW-PROFILE PORT-TITANIUM | Mar 22, 1994 | Substantially Equivalent |
| K933316 | THEREX LOW-PROFILE PORT DETACHED CATHETER SYSTEM | Feb 23, 1994 | Unknown |
| K933350 | THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CATHETER SYSTEM | Feb 23, 1994 | Unknown |