FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM
K Number: K942024
·
Decision Jul 26, 1994
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
287
Applicant Total
43
Review Days
91
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Basic Information
- Device Name
- PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM
- K Number
- K942024
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pharmacia Deltec, Inc.
- Date Received
- April 26, 1994
- Decision Date
- July 26, 1994
- 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 Pharmacia Deltec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K943310 | MODEL 6100 AMBULATORY INFUSION SYSTEM | Feb 21, 1995 | Substantially Equivalent - Subject to Tracking Reg. |
| K942046 | PHARMACIA DELTEC EXTENSION SET WITH ANTI-SIPHON VALVE | Oct 4, 1994 | Substantially Equivalent |
| K942161 | LOCKBOX | Aug 2, 1994 | Substantially Equivalent - Subject to Tracking Reg. |
| K941445 | EXTENSION SET WITH ANTI-SIPHON VALVE | Jun 29, 1994 | Substantially Equivalent |
| K931073 | CATH-FINDER | May 5, 1994 | Substantially Equivalent |
| K932430 | DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER | May 2, 1994 | Unknown |
| K932433 | PHERIPHERALLY INSERTED VENOUS CATHETER-Y SITE | May 2, 1994 | Unknown |
| K932198 | PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH | May 2, 1994 | Unknown |
| K932464 | PERIPHERALLYINSRTED VENOUS CATH. ALTERNATE CATH. | May 2, 1994 | Unknown |
| K932211 | PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS | May 2, 1994 | Substantially Equivalent |