I.V. STARTPAK VASCULAR ACCESS START KIT
FDA 510(k) clearance K942238 · decided 1994-06-03
Clearance details
- K-number
- K942238
- Device name
- I.V. STARTPAK VASCULAR ACCESS START KIT
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1994-05-09
- Decision date
- 1994-06-03
- Days to decision
- 25 days
- Clearance type
- Traditional
- Product code
- LRS
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sandy, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AMSINO I.V. START KIT (K050654) | Amsino International, Inc. | 2005-05-02 |
| INFUSION IV SET (K001879) | Nirvi Intl. USA | 2001-11-20 |
| IV START KIT (K963722) | Grand Medical Products | 1996-11-27 |
| EMS I.V. START KIT (K951167) | Emergency Medical Supply, Inc. | 1995-05-16 |
| B. BRAUN IV START KITS (K950184) | B. Braun of America, Inc. | 1995-03-15 |
| PERSONAL HEARING SYSTEM (K944041) | Resound Corp. | 1994-12-27 |
| SAFESTART VASCULAR ACCESS START KIT (K943941) | Becton Dickinson Vascular Access, Inc. | 1994-10-20 |
| IV START KIT (K935684) | Cush Medical Products | 1994-06-10 |
| IV START KIT (K941469) | Clinical Resources, Inc. | 1994-05-12 |
| IV PREP KIT (NON-STERILE) (K925017) | Customed, Inc. | 1993-08-27 |
| IV PREP KIT W/O DRESSING (NON-STERILE) (K925018) | Customed, Inc. | 1993-08-27 |
| COLD CD ASP MODULE, ITE (K933041) | Electone, Inc. | 1993-08-02 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |