FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DESERET (R) T-PORT (R) MULTI FLO(TM) AND DESERET (R)PRN ADAPTER
K Number: K950304
·
Decision Mar 14, 1995
Classifications
1
FEI Numbers
437
Registration Numbers
437
Same Product Code
1167
Applicant Total
25
Review Days
48
Basic Information
- Device Name
- DESERET (R) T-PORT (R) MULTI FLO(TM) AND DESERET (R)PRN ADAPTER
- K Number
- K950304
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BECTON DICKINSON VASCULAR ACCESS, INC.
- Date Received
- January 25, 1995
- Decision Date
- March 14, 1995
- Product Code
- FPA
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FPA), ordered by most recent decision date.
Clave Neutral-Displacement Needlefree Connectors
FDA 510(k)
FDA Class 2
·General Hospital
SteadiSet Infusion Set
FDA 510(k)
FDA Class 2
·General Hospital
JetCan® Pro Safety Huber Needle
FDA 510(k)
FDA Class 2
·General Hospital
Solution Administration Sets
FDA 510(k)
FDA Class 2
·General Hospital
Intravascular Extension Sets and Accessories
FDA 510(k)
FDA Class 2
·General Hospital
Lyka® PORT Needle Free Access Device (4170Y)
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by BECTON DICKINSON VASCULAR ACCESS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K971339 | INSYTE, INSYTE-W, INSYTE AUTOGUARD CATHETERS | Dec 24, 1997 | Substantially Equivalent |
| K970259 | E-Z SET INFUSION SET/SAF-T E-Z SET INFUSION SET | Apr 8, 1997 | Substantially Equivalent |
| K964048 | FIRST MIDCATH CATHETER KIT | Jan 6, 1997 | Substantially Equivalent |
| K964049 | FIRST MIDCATH CATHETER WITH DUAL LUMENS | Jan 6, 1997 | Substantially Equivalent |
| K964050 | FIRST MIDCATH CATHETER | Jan 6, 1997 | Substantially Equivalent |
| K954906 | FIRST PICC INTRODUCER CATHETER | Apr 8, 1996 | Substantially Equivalent |
| K952861 | ANGIOCATH & INSYTE AUTOGUARD CATHETERS | Jul 31, 1995 | Substantially Equivalent |
| K952757 | ANGIOCATH, NOVBALON, ANGIO-SET INTRAVASCULAR & ANGIOCATH INTRODUCTION DRAINAGE CATHETER | Jul 31, 1995 | Substantially Equivalent |
| K952053 | E-Z SET, SAF-T E-Z SET, AND MINICATH INFUSION SETS | May 31, 1995 | Substantially Equivalent |
| K950301 | ANGIOCATH(R) NONVALON(R) AND ANGIO-SET(R) IV CATHETERS | Apr 18, 1995 | Substantially Equivalent |