510(k) K941684
- Device
- IVEX-2 EXTENSION SET WITH Y-INJECTION SITE
- Applicant
- Abbott Laboratories
- 510(k) number
- K941684
- Product code
- FPB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1994-08-03
- Date received
- 1994-04-04
- Regulation
- 880.5440
- Classification name
- Filter, Infusion Line
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- FREDERICK A GUSTAFSON
- Address
- One Abbott Park Rd. D389, Ap30 Abbott Park IL US 60064 60064
FDA Registration Numbers#
- 3002807315
- 2650143
- 3006425876
- 9616567
- 3010173425
- 2029275
- 2245270
- 1530671
- 2528981
- 1220477
- 3016904853
- 3022555290
- 1718873
- 3030447506
- 3008412416
- 3011088743
- 1223004
- 9612003
- 8040700
- 3033536319
- 3002807314
- 3003704957
- 3012821221
- 9680602
- 3002807257
- 3009328501
- 3015276780
- 1416980
- 9680794
- 3008132398
- 8020892
- 3010132111
- 3005941719
- 3002907620
- 3013517171
- 3012307300
- 3012494290
- 1319639
- 1422078
- 3013557562
- 3003595336
- 3004569180
- 1061124
- 1057358
- 3012354669
- 1526534
- 3043226252
- 9612052
- 1423507
- 1526863
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FPB#
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|---|---|---|---|
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| K974661 | 0.2 U BACTERIAL FILTER | Sims Deltec, Inc. | 1998-02-11 |
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| K954331 | PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER) | Pall Biomedical Products Co. | 1997-01-09 |
| K933523 | I.V. FILTER SET | Mediziv Medical Products 1987 , Ltd. | 1995-05-19 |
| K941628 | 40 MICRON BLOOD TRANSFUSION FILTER | Douglas Medical Products Corp. | 1995-02-16 |
| K942625 | 1.2 MICRON AIR ELIMINATING FILTER | The Medi-Dose Group | 1994-10-07 |
| K943127 | PHARMASSURE LARGE VOLUME TRANSFER FILTERS | Gelman Sciences, Inc. | 1994-09-29 |
| K942532 | 2 MICRON AIR ELIMINATING FILTER | Medi-Dose, Inc. | 1994-08-17 |
| K942275 | VIAL VENT FILTER | Gelman Sciences, Inc. | 1994-07-26 |
| K940980 | CHARGED SUPOR(R) FILTER EXTENSION SET | B. Braun of America, Inc. | 1994-07-14 |