B-D FILTER NEEDLE
FDA 510(k) clearance K801343 · decided 1980-06-20
Clearance details
- K-number
- K801343
- Device name
- B-D FILTER NEEDLE
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1980-06-05
- Decision date
- 1980-06-20
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- FPB
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
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| Filter Needle for Single Use (K233277) | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-05-10 |
| Cathivex ¿GV filter units (K143583) | Merck Millipore , Ltd. | 2015-08-11 |
| NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER (K113227) | Baxter Healthcare Corp | 2011-12-08 |
| ARTERIA BLOOD FILTER (K021293) | Arteria Medical Science, Inc. | 2002-08-22 |
| PALL SUPOR AEF FILTER (K993379) | Pall Corp. | 1999-12-16 |
| 0.2 U BACTERIAL FILTER (K974661) | Sims Deltec, Inc. | 1998-02-11 |
| AUTOPRIME (K964283) | Arbor Technologies, Inc. | 1997-01-22 |
| PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) (K954331) | Pall Biomedical Products Co. | 1997-01-09 |
| I.V. FILTER SET (K933523) | Mediziv Medical Products 1987 , Ltd. | 1995-05-19 |
| 40 MICRON BLOOD TRANSFUSION FILTER (K941628) | Douglas Medical Products Corp. | 1995-02-16 |
| 1.2 MICRON AIR ELIMINATING FILTER (K942625) | The Medi-Dose Group | 1994-10-07 |
| PHARMASSURE LARGE VOLUME TRANSFER FILTERS (K943127) | Gelman Sciences, Inc. | 1994-09-29 |
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 |