510(k) K891005
- Device
- Intravascular Admini. Set Models 60030 & 60050
- Applicant
- 3M COMPANY
- 510(k) number
- K891005
- Product code
- FPK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-05-11
- Date received
- 1989-02-28
- Regulation
- 880.5440
- Classification name
- Tubing, Fluid Delivery
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- STANLEY J SUEDKAMP
- Address
- 1120 Red Fox Rd. St. Paul MN US 55112 55112
FDA Registration Numbers#
- 3013820501
- 3015173212
- 9617594
- 1423537
- 1038185
- 9616567
- 2024024
- 2245270
- 3004519921
- 1220477
- 1043214
- 9615050
- 3015309643
- 2523167
- 3006950086
- 3007007790
- 3011642792
- 2029015
- 1921846
- 3008692839
- 1223004
- 3033589330
- 1422634
- 1123137
- 2520313
- 1055236
- 8030107
- 3019807891
- 1625425
- 1649914
- 3004111573
- 1721676
- 1721504
- 1222637
- 8020616
- 9680306
- 3011237770
- 1644312
- 3022699058
- 3003974574
- 1724474
- 3010421104
- 2030624
- 2032112
- 3002907620
- 2011171
- 2433012
- 3009746061
- 1000604079
- 3014246639
- 3014936217
- 2032227
- 3015225571
- 1319639
- 1422078
- 3012536737
- 3016096098
- 3013319212
- 1054241
- 9612030
- 3004569180
- 1928237
- 1526534
- 2032098
- 3008403546
- 3004050971
- 3029973819
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code FPK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K131517 | MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING | Medrad, Inc. / Bayer Medical Care, Inc. | 2013-08-02 |
| K063114 | DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES | Coeur, Inc. | 2007-02-09 |
| K063239 | LIFESHIELD LATEX-FREE GRAVITECH FLOW CONTROLLER I.V. SETS, MODELS 17528, 17527, 17525 & 17526 | Hospira, Inc. | 2006-12-11 |
| K052431 | MEDTRONIC MINIMED LEAPFROG II INFUSION SET, MODELS MMT-801S1, MMT-801L1, MMT-801S2, MMT-801L2, MMT-803S1 | Medtronic Minimed | 2005-11-29 |
| K041178 | EMPOWER TRANSFER SET, (CAT. NO. 7725) | E-Z-Em, Inc. | 2004-07-16 |
| K031808 | MEDRAD SWABBABLE VALVE TRANSFER SET | Medrad, Inc. | 2003-07-11 |
| K022431 | MEDRAD TRANSFER SET | Medrad, Inc. | 2002-09-05 |
| K965208 | POLYFIN EXTENSION SET, MODELS 126 AND 128 | Medtronic Minimed | 1997-02-26 |
| K953864 | SILCLEAR TUBING (MODIFICATION) | Degania Silicone , Ltd. | 1995-11-06 |
| K950508 | SYSMEX SF-3000 | Sysmex Corp. | 1995-11-03 |
| K952243 | EXTENSION SET/I.V. SET | Coast Medical, Inc. | 1995-07-26 |
| K952663 | 60 MICRO VOLUME EXTENSION SET W/.22 MICRON FILTER, 21 EXTENSION SET W/1.2 MIVTON GILYRT, INJ. SITE, CLAMP | Distronic Sterile Products, Inc. | 1995-07-14 |
| K950861 | RECONSTITUTION ACCESSOREIS | Organon, Inc. | 1995-05-26 |
| K933524 | EXTENTION SET | Mediziv Medical Products 1987 , Ltd. | 1995-05-23 |
| K950200 | IVID | Scott/Ross Designs, Inc. | 1995-03-24 |