Panels › General Hospital › Product code OKE · Class 2
Port Introducer Kit
Regulation 880.5965
0510(k)s in 12 months (0 all time)
1recalls in 12 months (10 all time)
0recalls that name a 510(k)
Top companies in OKE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 27, 2026 | Windstone Medical Packaging, Inc. AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19 Open, Classified |
OKE | None listed |
| Oct 16, 2025 | American Contract Systems Inc. Medical convenience kits
UDPG88W PICC G-TUBE PACK-230209 Open, Classified |
OKE | None listed |
| Mar 14, 2025 | American Contract Systems Inc CENTRAL LINE PICC
, Model No LLCL44H
LLCL44H-01 Open, Classified |
OKE | None listed |
| Jan 26, 2024 | American Contract Systems, Inc. Custom procedural convenience kits and trays, general hospital use, labeled as:
a) Baby PICC Kit, kit number UIBP90J;
b) Baby PICC Kit, kit number UIBP90K;
c) PORT PACK (PS 058330), kit number UIP Open, Classified |
OKE | None listed |
| Oct 10, 2023 | Cardinal Health 200, LLC Procedure packs:
(1) Presource Portacath Pack, Cat. SANV1PIFSB, Medstar Franklin Square Med CE, Sterile; and
(2) Presource Bone Marrow Harvest Pack, Cat. SAN12BHGT1, Medstar Georgtown University H, S Open, Classified |
OKE | None listed |
| Jun 16, 2022 | American Contract Systems, Inc. Various Port Insertion Packs Open, Classified |
OKE | None listed |
| Jul 7, 2009 | Tri-State Hospital Supply Corporation Tri-State Hospital Supply Corp., Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code no./reorder KNV50. Each tray contains 1 sterile heparin flush injection solution as follows: Tyco H Terminated |
OKE | None listed |
| Jul 7, 2009 | Tri-State Hospital Supply Corporation Tri-State Hospital Supply Corp., Tri-State Centurion Port Blood Draw Trays, Qty/case 20, sterile, Code no./reorder DT9410B. Each tray contains 1 sterile heparin flush prefilled syringe as follows: T Terminated |
OKE | None listed |
| Jul 7, 2009 | Tri-State Hospital Supply Corporation Tri-State Hospital Supply Corp., Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code no./reorder DT9405B. Each tray contains 1 sterile heparin flush injection solution as follows: Ty Terminated |
OKE | None listed |
| Jul 7, 2009 | Tri-State Hospital Supply Corporation Tri-State Hospital Supply Corp., Tri-State Centurion Venous Access Port Kits, Qty/case 20, sterile, Code No./Reorder KNV80. Each kit contains 1 sterile heparin flush injection solution as follows: T Terminated |
OKE | None listed |
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