Q-Syte
Extension Set Rightbore15 cm (6 IN)
49manufacturers in China registered for this device type
11catalogue numbers in this listing
3510(k) clearances naming this product 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 | Becton, Dickinson AND Company, United States |
|---|---|
| FDA product code | FPA |
| Device type | Set, Administration, Intravascular |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5440 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K013621 |
| Record published | 2023-08-10 |
| Record revised | 2025-07-31 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry; Special storage condition: Keep away from sunlight |
| Packaging | Case of 50, case of 4, box of 25, case of 8, pack or inner pack of 25, box of 50 |
| Sizes | Length 6 in; total volume 0.16 ml |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 385106 | Size = Priming Volume = 0.16 millilitre (mL) | In distribution |
| 385156 | Length 6 in | In distribution |
| 385158 | Length 6 in | In distribution |
| 385150 | Length 6 in | In distribution |
| 385104 | Length 6 in | In distribution |
| 385151 | Length 6 in | In distribution |
| 385152 | Length 6 in | In distribution |
| 385161 | Length 6 in | In distribution |
| 385103 | Length 6 in | In distribution |
| 385157 | Length 6 in | In distribution |
| 385155 | Length 6 in | In distribution |
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 |
|---|---|
| K181718 | 2018-10-18 |
| K160651 | 2016-04-07 |
| K153257 | 2015-12-11 |
Recalls Naming This Product
11 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | 510(k) number | 2015-02-19 | Class II | Process control | Becton Dickinson received an elevated number of complaints for blood or infusate/medication leakage due to tearing of the silicone septum. | 315,800 units | 2017-05-25 |
| Medical Action Industries, Inc. 306 | 510(k) number | 2009-11-06 | Not classified | Nonconforming Material/Component | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | 12,000 kits | 2011-06-01 |
| Medical Action Industries, Inc. 306 | 510(k) number | 2009-11-06 | Not classified | Nonconforming Material/Component | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | 4,280 kits | 2011-06-01 |
| Medical Action Industries, Inc. 306 | 510(k) number | 2009-11-06 | Not classified | Nonconforming Material/Component | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | 2,520 kits | 2011-06-01 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2009-10-19 | Not classified | Process control | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | 950,000 units | 2010-10-19 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2009-10-19 | Not classified | Process control | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | 42,600 units | 2010-10-19 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2009-10-19 | Not classified | Process control | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | 144,900 units | 2010-10-19 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2009-10-19 | Not classified | Process control | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | 37,900 units | 2010-10-19 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2009-10-19 | Not classified | Process control | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | 73,050 units | 2010-10-19 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2009-10-19 | Not classified | Process control | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | 45,350 units | 2010-10-19 |
| Becton Dickinson Infusion Therapy Systems Inc. | 510(k) number | 2009-10-19 | Not classified | Process control | Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism. | 2,300 units | 2010-10-19 |
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.