GuideLiner® Navigation™ Catheter
Navigation catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of…
Navigation catheters are intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of guidewires and other interventional devices.
14manufacturers in China registered for this device type
4catalogue numbers in this listing
27510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Covidien Medical Products (Shanghai) Manufacturing LLC | Shanghai | Shanghai | Contract manufacturer | 8 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Goals Sterilization Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 26 |
| Wuxi Goals Medical Technology Co., Ltd. | Yixing | Jiangsu | Contract manufacturer | 24 |
| Suzhou Zenith Vascular Scitech Limited | Suzhou | Jiangsu | Manufacturer | 6 |
| Haolang Technology (Foshan) Limited Corporation | Foshan | Guangdong | Contract manufacturer | 6 |
| OrbusNeich Medical (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Complaint-file establishment | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Shanghai Wallaby Medical Technologies Co., Inc. | Shanghai | Shanghai | Contract manufacturer | 5 |
| DK Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Showing 12 of 14. All 14 manufacturers in China registered for Catheter, Percutaneous
Record
| Listed by | Vascular Solutions LLC, United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-09-05 |
| Record revised | 2021-12-22 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Catheter gauge 5.5 to 8 Fr |
| Distribution end date | 2019-09-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5470 | Catheter Gauge 5.5 Fr | Withdrawn |
| 5471 | Catheter Gauge 6 Fr | Withdrawn |
| 5473 | Catheter Gauge 8 Fr | Withdrawn |
| 5472 | Catheter Gauge 7 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Launcher™ | Medtronic, Inc. | 3,805 |
| Sherpa NX Balanced™ | Medtronic, Inc. | 1,523 |
| Arrow | Teleflex Medical LLC | 1,249 |
| Z2 | Medtronic, Inc. | 955 |
| Vista Brite TIP | Cordis Corp. | 789 |
| Mach1™ | Boston Scientific Corporation | 777 |
| Sherpa NX Active | Medtronic, Inc. | 571 |
| Zuma® | Medtronic, Inc. | 569 |
| Convey | Pendracare International B.V. | 532 |
| Taiga | Medtronic, Inc. | 307 |
| RunWay™ | Boston Scientific Corporation | 300 |
| ConcierGE Guiding Excellence™ | Merit Medical Systems, Inc. | 295 |
Showing 12 of 500. All products under Catheter, Percutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K220647 | 2022-08-18 |
| K212211 | 2022-02-09 |
| K210647 | 2021-04-30 |
| K193119 | 2020-06-29 |
| K191560 | 2019-08-09 |
| K182570 | 2019-03-13 |
| K180088 | 2018-04-04 |
| K172090 | 2017-10-20 |
| K171335 | 2017-06-07 |
| K161901 | 2017-02-03 |
| K162467 | 2017-02-01 |
| K142065 | 2014-11-25 |
| K133501 | 2014-02-25 |
| K120707 | 2012-05-15 |
| K112100 | 2012-03-20 |
| K112082 | 2011-12-01 |
| K111334 | 2011-08-01 |
| K101659 | 2010-12-16 |
| K091750 | 2009-11-04 |
| K090977 | 2009-06-18 |
| K091345 | 2009-06-12 |
| K082337 | 2009-01-15 |
| K072618 | 2007-11-21 |
| K070372 | 2007-06-01 |
| K060327 | 2006-04-12 |
| K052258 | 2005-12-13 |
| K052257 | 2005-11-23 |
Recalls
3 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2017-04-25 | Class I | Process control | Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential problem. Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS (Model 5822) catheters. After an internal investigation, VSI | 13,551 (7,054 are unexpired) | 2019-11-05 |
| 2016-09-16 | Class I | Process control | Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. | 11,670 units total | 2018-05-04 |
| 2016-09-16 | Class I | Process control | Vascular Solutions is recalling Twin-Pass dual access catheters because there is a potential for excess manufacturing material to remain at the tip of the catheter or within the distal portion of the rapid exchange lumen. | 11,670 units total | 2018-05-04 |
| 2013-01-29 | Class II | Material/Component Contamination | Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing. | 4731 | 2013-06-25 |
| 2012-01-17 | Not classified | Material/Component Contamination | Vascular Solutions has became aware of a potential defect with their 6F GuideLiner V2 catheters (Model 5571) with lot number 555038. Use of this product could result in the catheter shaft separating from the pushwire on the device. This may | 330 | 2012-07-19 |
| 2009-07-02 | Not classified | Process control | Three occurrences of Twin-Pass catheters containing a piece of PTFE beading material in the OTW lumen have been reported to Vascular Solutions. The PTFE beading material is a processing aide used during hydrophilic coating. The beading is t | 5885 | 2012-04-03 |
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.