Deltec
130 catalogue numbers from 21-4452-24, listed by ICU Medical, Inc, United States, under Port & Catheter, Implanted, Subcutaneous, Intravascular. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
130catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
Record
| Listed by | ICU Medical, Inc, United States |
|---|---|
| FDA product code | LJT |
| Device type | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5965 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K072657 |
| Record published | 2015-09-01 |
| Record revised | 2025-04-16 (version 10) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 12 |
| Distribution end date | 2020-09-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 21-4452-24 | In distribution | |
| 21-4476-24 | In distribution | |
| 21-4050-24 | In distribution | |
| 21-4482-24 | In distribution | |
| 21-8468-24 | In distribution | |
| 21-4084-24 | In distribution | |
| 21-8011-24 | In distribution | |
| 21-4672-24 | In distribution | |
| 21-4873-01 | In distribution | |
| 21-4154-24 | In distribution | |
| 21-4070-24 | In distribution | |
| 21-4069-24 | In distribution | |
| 21-2005-24 | In distribution | |
| 21-2007-24 | In distribution | |
| 21-4054-24 | In distribution | |
| 21-4160-24 | In distribution | |
| 21-4436-24 | In distribution | |
| 21-4151-24 | In distribution | |
| 21-4036-24 | In distribution | |
| 21-2014-24 | In distribution | |
| 21-4572-24 | In distribution | |
| 21-4165-24 | In distribution | |
| 21-4071-24 | In distribution | |
| 21-4873-24 | In distribution | |
| 21-4187-24 | In distribution | |
| 21-4155-24 | In distribution | |
| 21-4591-24 | In distribution | |
| 21-4140-22 | In distribution | |
| 21-4010-24 | In distribution | |
| 21-8050-24 | In distribution | |
| 21-4067-24 | In distribution | |
| 21-4185-24 | In distribution | |
| 21-4150-24 | In distribution | |
| 21-4053-24 | In distribution | |
| 21-4065-24 | In distribution | |
| 21-8066-24 | In distribution | |
| 21-4066-24 | In distribution | |
| 21-8070-24 | In distribution | |
| 21-4000-24 | In distribution | |
| 21-4423-24 | In distribution | |
| 21-4455-24 | In distribution | |
| 21-4052-24 | In distribution | |
| 21-4171-24 | In distribution | |
| 21-8068-24 | In distribution | |
| 21-4474-24 | In distribution | |
| 21-4035-24 | In distribution | |
| 21-4470-24 | In distribution | |
| 21-4162-24 | In distribution | |
| 21-4085-24 | In distribution | |
| 21-4172-24 | In distribution | |
| 21-2006-24 | In distribution | |
| 21-4425-24 | In distribution | |
| 21-4003-24 | In distribution | |
| 21-2317-24 | In distribution | |
| 21-8466-24 | In distribution | |
| 21-4465-24 | In distribution | |
| 21-4182-24 | In distribution | |
| 21-4463-24 | In distribution | |
| 21-2026-24 | In distribution | |
| 21-2008-24 | In distribution | |
| 21-4004-24 | In distribution | |
| 21-4037-24 | In distribution | |
| 21-4170-24 | In distribution | |
| 21-4068-24 | In distribution | |
| 21-4051-24 | In distribution | |
| 21-8010-24 | In distribution | |
| 21-4189-24 | In distribution | |
| 21-4034-24 | In distribution | |
| 21-2022-24 | In distribution | |
| 21-4152-24 | In distribution | |
| 21-4473-24 | In distribution | |
| 21-4009-24 | In distribution | |
| 21-4573-24 | In distribution | |
| 21-4475-24 | In distribution | |
| 21-4453-24 | In distribution | |
| 21-4023-24 | In distribution | |
| 21-4454-24 | In distribution | |
| 21-8052-24 | In distribution | |
| 21-8465-24 | In distribution | |
| 21-4024-24 | In distribution | |
| 21-4184-24 | In distribution | |
| 21-8069-24 | In distribution | |
| 21-4083-24 | In distribution | |
| 21-8470-24 | In distribution | |
| 21-4025-24 | In distribution | |
| 21-4183-24 | In distribution | |
| 21-8065-24 | In distribution | |
| 21-4590-24 | In distribution | |
| 21-2021-24 | In distribution | |
| 21-4424-24 | In distribution | |
| 21-4471-24 | In distribution | |
| 21-4073-24 | In distribution | |
| 21-4008-24 | In distribution | |
| 21-8469-24 | In distribution | |
| 21-2016-24 | In distribution | |
| 21-4082-24 | In distribution | |
| 21-4055-24 | In distribution | |
| 21-4437-24 | In distribution | |
| 21-4153-24 | In distribution | |
| 21-4483-24 | In distribution | |
| 21-4872-24 | In distribution | |
| 21-2015-24 | In distribution | |
| 21-4477-24 | In distribution | |
| 21-2013-24 | In distribution | |
| 21-4173-24 | In distribution | |
| 21-4872-01 | In distribution | |
| 21-2316-24 | In distribution | |
| 21-4063-24 | In distribution | |
| 21-4485-24 | In distribution | |
| 21-4422-24 | In distribution | |
| 21-4186-24 | In distribution | |
| 21-4164-24 | In distribution | |
| 21-4022-24 | In distribution | |
| 21-4955-24 | Withdrawn | |
| 21-4691-24 | Withdrawn | |
| 21-4188-24 | Withdrawn | |
| 21-4683-24 | Withdrawn | |
| 21-4690-24 | Withdrawn | |
| 21-4685-24 | Withdrawn | |
| 21-4972-24 | Withdrawn | |
| 21-8053-24 | Withdrawn | |
| 21-3000-24 | Withdrawn | |
| 21-4953-24 | Withdrawn | |
| 21-4973-24 | Withdrawn | |
| 21-4985-24 | Withdrawn | |
| 21-4673-24 | Withdrawn | |
| 21-4983-24 | Withdrawn | |
| 21-4161-24 | Withdrawn | |
| 21-4163-24 | Withdrawn | |
| 21-8067-24 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dignity® | Medical Components Inc | 168 |
| NorPort Vascular Access Port | Norfolk Medical | 106 |
| BioFlo Vortex | AngioDynamics, Inc. | 60 |
| BioFlo Vortex | Navilyst Medical, Inc. | 59 |
| Dignity® MID-Sized CT Port | Medical Components Inc | 55 |
| TidalPort Vascular Access Port | Norfolk Medical | 52 |
| Pro-Fuse® Low Profile CT Port | Medical Components Inc | 45 |
| Dignity® Low Profile CT Port | Medical Components Inc | 45 |
| Dignity® Mini CT Port | Medical Components Inc | 44 |
| Medcomp GEN III Power Injectable Portmedcomp GEN III Power Injectable Port | Medical Components Inc | 29 |
| PRO-Fuse® | Medical Components Inc | 28 |
| Xcela | Navilyst Medical, Inc. | 28 |
Showing 12 of 96. All products under Port & Catheter, Implanted, Subcutaneous, Intravascular
Recalls Naming This Product
31 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Smiths Medical Asd, Inc. | UDI-DI | 2025-02-13 | Class I | Process control | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. | 3 units | |
| Smiths Medical Asd, Inc. | UDI-DI | 2025-02-13 | Class I | Process control | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. | 643 units | |
| Smiths Medical Asd, Inc. | UDI-DI | 2025-02-13 | Class I | Process control | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. | 2311 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2025-02-13 | Class I | Process control | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. | 9506 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2025-02-13 | Class I | Process control | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. | 3263 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2025-02-13 | Class I | Process control | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. | 1695 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2025-02-13 | Class I | Process control | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. | 1961 units | |
| Smiths Medical Asd, Inc. | UDI-DI | 2025-02-13 | Class I | Process control | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. | 1 unit | |
| Smiths Medical Asd, Inc. | UDI-DI | 2025-02-13 | Class I | Process control | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. | 12 units | |
| Smiths Medical Asd, Inc. | UDI-DI | 2025-02-13 | Class I | Process control | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. | 0 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2025-02-13 | Class I | Process control | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. | 8515 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2025-02-13 | Class I | Process control | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. | 2236 units | |
| Smiths Medical Asd, Inc. | 510(k) number | 2020-06-11 | Class II | Under Investigation by firm | Smiths Medical became aware that one (1) lot of PORT-A-CATH II POWER P.A.C. Low Profile” System (SKU 21-4477-24) was packaged with an 8Fr catheter instead of a 6Fr catheter. | 46 kits | 2021-01-25 |
| Smiths Medical Asd, Inc. | 510(k) number | 2019-07-08 | Class II | Process control | Potential for certain GRIPPER Needles to contain an occluded or blocked needle. | 3,952,509 devices total | 2020-08-23 |
| Smiths Medical Asd, Inc. | 510(k) number | 2017-12-04 | Class II | Process design | Certain models and lots of PORT A CATH implantable port kits may have been misassembled. The kits may incorrectly contain a 6Fr or 6.5Fr size introducer instead of the correct 8.5Fr size introducer. The Power PORT A CATH II kit may also con | 1,077 units total | 2020-06-12 |
| Smiths Medical Asd, Inc. | 510(k) number | 2015-09-14 | Class II | Labeling mix-ups | The label on the lid stock of the individual needle packages for a portion of Lot number 46262 contains the incorrect part number, part number description and product image. The part number should be 21-2287-24 Port-A-Cath Plastic Hub Bent | 130 Cartons (1560 needles) | 2016-05-09 |
| Smiths Medical Asd, Inc. | 510(k) number | 2013-09-10 | Class II | Mixed-up of materials/components | Smiths Medical is conducting a voluntary recall of PORT-A-CATH and PORT-A-CATH II Implantable Venous and Arterial Access Systems and Introducer Sets. Smiths Medical has become aware of a small number of customer reports regarding the intro | 372 | 2014-10-21 |
| Smiths Medical MD, Inc. | 510(k) number | 2004-11-11 | Not classified | Other | The catheter became disconnected from the port while implanted in the patient. | 75 trays | 2005-11-14 |
| Deltec, Inc. | 510(k) number | 2004-03-29 | Not classified | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. | 2006-12-28 | |
| Deltec, Inc. | 510(k) number | 2004-03-29 | Not classified | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. | 2006-12-28 | |
| Deltec, Inc. | 510(k) number | 2004-03-29 | Not classified | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. | 2006-12-28 | |
| Deltec, Inc. | 510(k) number | 2004-03-29 | Not classified | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. | 2006-12-28 | |
| Deltec, Inc. | 510(k) number | 2004-03-29 | Not classified | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. | 2006-12-28 | |
| Deltec, Inc. | 510(k) number | 2004-03-29 | Not classified | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. | 2006-12-28 | |
| Deltec, Inc. | 510(k) number | 2004-03-29 | Not classified | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. | 2006-12-28 | |
| Deltec, Inc. | 510(k) number | 2004-03-29 | Not classified | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. | 2006-12-28 | |
| Deltec, Inc. | 510(k) number | 2004-03-29 | Not classified | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. | 2006-12-28 | |
| Deltec, Inc. | 510(k) number | 2004-03-29 | Not classified | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. | 2006-12-28 | |
| Deltec, Inc. | 510(k) number | 2004-03-29 | Not classified | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. | 2006-12-28 | |
| Deltec, Inc. | 510(k) number | 2004-03-29 | Not classified | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. | 2006-12-28 | |
| Deltec, Inc. | 510(k) number | 2004-03-29 | Not classified | Other | Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after sterilization. | 2006-12-28 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA.
Records are records: nothing here is an offer of sale.