FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PORT-A-CATH PORTAL INTRODUCER FORCEPS
K Number: K881690
·
Decision May 20, 1988
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
7
Applicant Total
43
Review Days
31
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Basic Information
- Device Name
- PORT-A-CATH PORTAL INTRODUCER FORCEPS
- K Number
- K881690
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5550
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Pharmacia Deltec, Inc.
- Date Received
- April 19, 1988
- Decision Date
- May 20, 1988
- Product Code
- LKG
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| LKG | Port & Catheter, Implanted, Subcutaneous, Intraventricular | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKG), ordered by most recent decision date.
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HH SUBCUTANEOUS ACCESS PORT
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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. |
| K942024 | PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM | Jul 26, 1994 | Substantially Equivalent |
| 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 |