FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932
K Number: K960055
·
Decision Sep 30, 1996
Classifications
1
FEI Numbers
90
Registration Numbers
90
Same Product Code
301
Applicant Total
40
Review Days
270
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Basic Information
- Device Name
- MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932
- K Number
- K960055
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5970
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pudenz-Schulte Medical Research Corp.
- Date Received
- January 4, 1996
- Decision Date
- September 30, 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 Pudenz-Schulte Medical Research Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K954409 | PS MEDICAL IPI VASCULAR ACCESS CATHETER | Dec 18, 1995 | Substantially Equivalent |
| K951258 | PS MEDICAL BIOGLIDE CSF-FLOW CONTROL SHUNT KIT | Sep 18, 1995 | Substantially Equivalent |
| K934796 | IPI LOW PROFILE IMPORT | Jul 14, 1994 | Substantially Equivalent |
| K934167 | IPI DUAL LUMEN PORT | Jul 14, 1994 | Substantially Equivalent |
| K940096 | PS MEDICAL CATHETER PLACEMENT KIT | May 3, 1994 | Substantially Equivalent |
| K934545 | PS MEDICAL DELTA BURR HOLE VALVE | Apr 28, 1994 | Substantially Equivalent |
| K930206 | PS MEDICAL IPI ACCESS KIT | Feb 25, 1994 | Unknown |
| K930606 | PS MEDICAL DISPOSABLE SUBCUTANEOUS CATH PASSER | Sep 10, 1993 | Substantially Equivalent |
| K913412 | PS MEDICAL CSF-ACCESS DEVICE | Mar 30, 1993 | Substantially Equivalent |
| K922419 | IPI IMPORT | Nov 20, 1992 | Substantially Equivalent |