FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BARDPORT TITANIUM PORTS
K Number: K050310
·
Decision Apr 18, 2005
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
285
Applicant Total
14
Review Days
69
Basic Information
- Device Name
- BARDPORT TITANIUM PORTS
- K Number
- K050310
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BARD ACCESS SYSTEMS, INC.
- Date Received
- February 8, 2005
- Decision Date
- April 18, 2005
- 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 BARD ACCESS SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
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| K071095 | ASPIRA PLEURAL DRAINAGE SYSTEM | May 18, 2007 | Substantially Equivalent |
| K053589 | LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING | Apr 13, 2006 | Substantially Equivalent |
| K053501 | POWERPICC | Jan 13, 2006 | Substantially Equivalent |
| K051672 | POWERPICC | Nov 23, 2005 | Substantially Equivalent |
| K042445 | SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT | Oct 19, 2004 | Substantially Equivalent |
| K971990 | GESCO PER-Q-CATH PICC CATHETERS | Nov 7, 1997 | Substantially Equivalent |
| K971991 | GESCO PER-Q-CATH MIDLINE CATHETERS | Nov 7, 1997 | Substantially Equivalent |
| K935380 | VASCULAR ACCESS CATHETER ACCESSORIES | Feb 17, 1995 | Substantially Equivalent |