Smart Port CT
Smart Port CT Single Titanium Port System with Attachable 8.0F x 66cm Polyurethane Catheter and 8 F Introducer Kit (with Valved Introducer and Non-Filled Suture Holes)
49manufacturers in China registered for this device type
19catalogue numbers in this listing
3510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Zhejiang (12), Jiangsu (11), Shanghai (10). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 9 |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 7 |
| JDI Electronics Factory | Dongguan | Guangdong | Contract manufacturer | 7 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Wenzhou K.L.F. Medical Plastics Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| Advance Technology Ltd | Shenzhen | Guangdong | Contract manufacturer | 3 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
Showing 12 of 49. All 49 manufacturers in China registered for Set, Administration, Intravascular
Record
| Listed by | AngioDynamics, Inc., United States |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K062414 |
| Record published | 2024-07-23 |
| Record revised | 2024-07-23 (version 8) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 10 to 27 °C |
| Sizes | Catheter gauge 7.5 to 9.6 Fr; outer diameter 2.5 to 3.2 mm; length 66 cm; lumen/inner diameter 1.4 to 1.6 mm |
| Distribution end date | 2024-07-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| H787CT96STSA0 | Catheter Gauge 9.6 Fr | In distribution |
| H787CT80STPD0 | Outer Diameter 2.7 mm | In distribution |
| H787CT96STSDNF0 | Lumen/Inner Diameter 1.6 mm | In distribution |
| H787CT96STSDNFVI1 | Length 66 cm | In distribution |
| CT80STPD-NFVI | Lumen/Inner Diameter 1.5 mm | In distribution |
| H787CT80STPAVI1 | Catheter Gauge 8 Fr | In distribution |
| H787CT80STPA0 | Length 66 cm | In distribution |
| H787CT75STSA0 | Outer Diameter 2.5 mm | In distribution |
| H787CT80STPDVI1 | Outer Diameter 2.7 mm | In distribution |
| CT96STSD-NFVI | Outer Diameter 3.2 mm | Withdrawn |
| CT96STSD | Outer Diameter 3.2 mm | Withdrawn |
| CT75STSD-VI | Lumen/Inner Diameter 1.4 mm | Withdrawn |
| CT80STPD | Length 66 cm | Withdrawn |
| CT75STSD-NFVI | Outer Diameter 2.5 mm | Withdrawn |
| CT96STSA | Catheter Gauge 9.6 Fr | Withdrawn |
| CT80STPA-VI | Lumen/Inner Diameter 1.5 mm | Withdrawn |
| CT75STSA | Lumen/Inner Diameter 1.4 mm | Withdrawn |
| CT96STSD-VI | Catheter Gauge 9.6 Fr | Withdrawn |
| CT96STSA-VI | Outer Diameter 3.2 mm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ICU Medical | ICU Medical, Inc | 529 |
| Codan | Codan US Corp. | 510 |
| Vygon | Vygon Corp. | 355 |
| Port Access Needle | Bard Access Systems, Inc. | 341 |
| Set, Administration, Intravascular | Mps Medical, Inc. | 291 |
| Alaris, SmartSite | BD Switzerland Sàrl | 266 |
| IV Administration Set | B. Braun Medical Inc. | 242 |
| Medex | ICU Medical, Inc | 237 |
| Extension Set | B. Braun Medical Inc. | 171 |
| MaxGuard | BD Switzerland Sàrl | 150 |
| Medline | Medline Industries, Inc. | 148 |
| Centurion | Centurion Medical Products Corporation | 145 |
Showing 12 of 768. All products under Set, Administration, Intravascular
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K072375 | 2007-12-13 |
| K051142 | 2005-07-13 |
| K953825 | 1996-02-26 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| AngioDynamics, Inc. | 510(k) number | 2021-02-22 | Class II | Under Investigation by firm | AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device. Only the specific product/lot of the kit identified be | 267 kits | 2022-07-19 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2017-01-13 | Class II | Under Investigation by firm | The product has the potential to be non-sterile as it was not packaged in accordance to specification. | 8 boxes/25 units | 2018-06-25 |
| 2013-11-25 | Class II | Device Design | Navilyst Medical has recalled a Port Kit with Access Infusion Set due to a possible breach of sterilization barrier. | 920 Total kits | 2017-03-10 |
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.