510(k) K962931
- Device
- SIMS PRO-VENT 250 (500) PLUS ARTERIAL BLOOD SAMPLING KIT
- Applicant
- SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
- 510(k) number
- K962931
- Product code
- JKA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-10-21
- Date received
- 1996-07-29
- Regulation
- 862.1675
- Classification name
- Tubes, Vials, Systems, Serum Separators, Blood Collection
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- TIMOTHY J TALCOTT
- Address
- 15 Kit St. Keene NH US 03431 03431
FDA Registration Numbers#
- 3026940910
- 3010421104
- 3015058854
- 3002807408
- 8041145
- 3008449424
- 1063851
- 3007135420
- 2018685
- 8021538
- 3003974574
- 3020831613
- 3035708936
- 1933913
- 3003120666
- 3043051314
- 3015309643
- 3028019212
- 3030733800
- 2028807
- 3010934635
- 2618282
- 1054811
- 3006285950
- 1647137
- 3008717264
- 3013652330
- 3014162214
- 3000247873
- 3013513377
- 3013557562
- 3015972753
- 3039435934
- 2320762
- 3009889060
- 1054241
- 9680222
- 3009742443
- 3030446844
- 2032521
- 3012502601
- 3015173212
- 9617475
- 1423537
- 3041276591
- 3008733163
- 3015276780
- 3014456066
- 3010621964
- 3010405396
- 3022964615
- 3022147580
- 3030419987
- 1055236
- 3001124136
- 3031789039
- 3008272066
- 1060680
- 3003744503
- 3014654360
- 3012116434
- 3013187142
- 3004140833
- 1043214
- 3015453963
- 9680448
- 3014570560
- 2648045
- 3021169199
- 8041187
- 3010515547
- 3012187973
- 3006425876
- 1921846
- 3004153557
- 3012494290
- 3017923561
- 9615908
- 3013188547
- 3019807891
Source Documents#
Other 510(k) Records For Product Code JKA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262215 | Profoject™ Safety Sliding Blood Collection Set | CMT Health PTE., Ltd. | 2026-09-25 |
| K252899 | Female Culture Device; Male Culture Device; Transfer Device; Access Device | Zhejiang Kindly Medical Device Co., Ltd. | 2026-06-02 |
| K260128 | BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes | Becton, Dickinson and Company | 2026-04-15 |
| K252378 | BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube | Becton, Dickinson and Company | 2026-04-10 |
| K252506 | BD Vacutainer® Safety-Lok™ Blood Collection Set; BD Vacutainer® Safety-Lok™ Blood Collection Set with Pre-Attached Holder | Becton, Dickinson and Company | 2026-04-10 |
| K252040 | BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes | Becton, Dickinson and Company | 2026-03-13 |
| K251812 | Steripath® Flow™ Blood Collection System | Magnolia Medical Technologies | 2025-09-25 |
| K243207 | BD Vacutainer® Eclipse™ Blood Collection Needle | Becton, Dickinson and Company | 2025-07-03 |
| K250961 | Blood collection tube holders | Promisemed Hangzhou Meditech Co., Ltd. | 2025-06-04 |
| K244047 | Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) | Venocare, Inc. | 2025-05-23 |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | Sol-Millennium Medical, Inc. | 2025-04-30 |
| K243649 | BD Vacutainer® Multiple Sample Luer Adapter | Becton, Dickinson and Company | 2025-03-21 |
| K241586 | PIVO™ Pro Needle-free Blood Collection Device | Becton Dickinson Infusion Therapy Systems, Inc. | 2025-02-27 |
| K242320 | BD Vacutainer® One Use Holder | Becton, Dickinson and Company | 2024-11-01 |
| K233979 | VACUETTE® QUICKSHIELD Complete (Plus) | Greiner Bio-One North America, Inc. | 2024-07-19 |
Legacy Summary#
summary
FDA Review#
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