Medcomp PRO-Picc With Valve Technolgoymedcomp PRO-Picc With Valve Technolgoy
6F X 60CM Triple LUMEN6F X 60CM PRO-Picc®ct W/Valve Technologytechnology Catheter Onlycatheter Only
5manufacturers in China registered for this device type
1catalogue number
9510(k) clearances naming this product code
5recalls on this code
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (1), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Chison Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 5 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
Record
| Listed by | Medical Components Inc, United States |
|---|---|
| FDA product code | LJS |
| Device type | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5970 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-04-09 |
| Record revised | 2021-02-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10 |
| Distribution end date | 2020-01-16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MD82036300 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arrow | Teleflex Medical LLC | 1,548 |
| BioFlo | Navilyst Medical, Inc. | 658 |
| PowerPICC | Bard Access Systems, Inc. | 477 |
| PowerPICC Solo | Bard Access Systems, Inc. | 333 |
| PowerPICC Provena | Bard Access Systems, Inc. | 312 |
| Xcela | Navilyst Medical, Inc. | 271 |
| PRO-Picc® CT | Medical Components Inc | 157 |
| Vascu-Picc® | Medical Components Inc | 135 |
| Turbo-Ject | Cook Incorporated | 94 |
| Cook Spectrum Turbo-Ject | Cook Incorporated | 73 |
| Vascu-Picc®and Midline Catheters | Medical Components Inc | 55 |
| Synergy | Health Line International Corporation | 53 |
Showing 12 of 194. All products under Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141633 | 2014-09-29 |
| K131687 | 2013-08-16 |
| K123617 | 2013-05-15 |
| K122423 | 2012-12-12 |
| K121094 | 2012-06-06 |
| K120980 | 2012-05-02 |
| K120981 | 2012-05-02 |
| K003682 | 2001-01-26 |
| K983412 | 1998-12-10 |
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 |
|---|---|---|---|---|---|
| 2018-10-01 | Class II | Software Manufacturing/Software Deployment | When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or internal mode. If the C3 application is not operating pro | 24 | 2020-10-01 |
| 2012-12-13 | Class II | Nonconforming Material/Component | The affected product was packaged with the incorrect introducer needle. The kit label indicates a “safety” needle is included; the kits were packaged with a non-safety needle. | 785 | 2013-07-31 |
| 2008-04-11 | Not classified | Mixed-up of materials/components | kit contains incorrect component | 250 units | 2008-10-28 |
| 2005-09-15 | Not classified | Other | The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 4F | 10 units | 2005-11-22 |
| 2005-09-15 | Not classified | Other | The product is labelled as containing a 4F catheter when the trays/kits actually contain a 5F catheter. The catheters will not fit into the sheath-dilator that was included in the tray. mislabeled as 4F | 88 units | 2005-11-22 |
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.