Vista Brite TIP
GC 6F.070 Inches 100CM JL5 MOD Exte
14manufacturers in China registered for this device type
789catalogue numbers in this listing
22510(k) clearances naming this product 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 | Cordis Corp., United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| 510(k) | K021593 |
| Record published | 2016-08-01 |
| Record revised | 2024-08-09 (version 13) |
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 |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Box of 5, box |
| Distribution end date | 2024-08-08 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SM7501 | In distribution | ||
| MODG17646 | In distribution | ||
| SM7402 | In distribution | ||
| G5888108 | In distribution | ||
| SM7344 | In distribution | ||
| G56L0AL1 | In distribution | ||
| 67021455 | In distribution | ||
| SM7508 | In distribution | ||
| SM7309 | In distribution | ||
| MODG17824 | In distribution | ||
| SM7650 | In distribution | ||
| G672JR25F | In distribution | ||
| SM7378 | In distribution | ||
| 77805600 | In distribution | ||
| G882LCBH | In distribution | ||
| 4038953M | In distribution | ||
| SM7577 | In distribution | ||
| SM7548 | In distribution | ||
| G782JCL35 | In distribution | ||
| SM7435 | In distribution | ||
| SM7288 | In distribution | ||
| G782JCR5 | In distribution | ||
| G780NR4 | In distribution | ||
| SM7570 | In distribution | ||
| G670RCBH | In distribution | ||
| SM6915 | In distribution | ||
| 67008400 | In distribution | ||
| 77822255 | In distribution | ||
| 67016400 | In distribution | ||
| 77808500 | In distribution | ||
| G880XBLAD5 | In distribution | ||
| SM7374 | In distribution | ||
| 4038953B | In distribution | ||
| SM7394 | In distribution | ||
| G667637 | In distribution | ||
| 67005300 | In distribution | ||
| 77808390 | In distribution | ||
| G67L0HSH | In distribution | ||
| 4038553M | In distribution | ||
| 7780830E | In distribution | ||
| 77806000 | In distribution | ||
| SM7699 | In distribution | ||
| SM7465 | In distribution | ||
| 77818200 | In distribution | ||
| SM7424 | In distribution | ||
| SM7429 | In distribution | ||
| SM7423 | In distribution | ||
| 77801200 | In distribution | ||
| 77806300 | In distribution | ||
| SM7166 | In distribution | ||
| SM7714 | In distribution | ||
| 4038553R | In distribution | ||
| G672JR2 | In distribution | ||
| MODG18859 | In distribution | ||
| SM7396 | In distribution | ||
| G780RCBH | In distribution | ||
| MODG18609 | In distribution | ||
| SM7687 | In distribution | ||
| 4037553C | In distribution | ||
| 77804200 | In distribution | ||
| 77805500 | In distribution | ||
| SM7355 | In distribution | ||
| 67004100 | In distribution | ||
| G880AL1N | In distribution | ||
| SM7740 | In distribution | ||
| X8850 | In distribution | ||
| SM7621 | In distribution | ||
| 77818300 | In distribution | ||
| G880JL35A | In distribution | ||
| 77800800 | In distribution | ||
| G672JR4H | In distribution | ||
| SM7641 | In distribution | ||
| SM7604 | In distribution | ||
| SM7464 | In distribution | ||
| 4037553A | In distribution | ||
| 67004200 | In distribution | ||
| 6700820E | In distribution | ||
| SM6583 | In distribution | ||
| SM7673 | In distribution | ||
| SRA0002IG | In distribution | ||
| SM7503 | In distribution | ||
| MODG16654 | 2 | In distribution | |
| SM7703 | In distribution | ||
| G670CH2 | In distribution | ||
| SM7730 | In distribution | ||
| SM7660 | In distribution | ||
| SM7620 | In distribution | ||
| SM7399 | In distribution | ||
| SM7638 | In distribution | ||
| SM7477 | In distribution | ||
| SM7696 | In distribution | ||
| SM7677 | In distribution | ||
| G672AL3 | In distribution | ||
| G670CAS1F | In distribution | ||
| 67017200 | In distribution | ||
| SM7362 | In distribution | ||
| SM7728 | In distribution | ||
| 77803400 | In distribution | ||
| 6702700L | In distribution | ||
| G670IMSTH | In distribution | ||
| 6700540L | In distribution | ||
| G672VL4 | In distribution | ||
| G780AL4 | In distribution | ||
| SM7752 | In distribution | ||
| SM7702 | In distribution | ||
| 67012700 | In distribution | ||
| SM7408 | In distribution | ||
| 77806100 | In distribution | ||
| 67005400 | In distribution | ||
| 67005500 | In distribution | ||
| G672JR4F | In distribution | ||
| 67007300 | In distribution | ||
| 6701120L | In distribution | ||
| SM7279 | In distribution | ||
| 67021890 | In distribution | ||
| 77819090 | In distribution | ||
| G782AL4 | In distribution | ||
| SM7666 | In distribution | ||
| SM7409 | In distribution | ||
| SM7474 | In distribution | ||
| SM7395 | In distribution | ||
| SM7488 | In distribution | ||
| 6700400L | In distribution | ||
| 588823E | In distribution | ||
| MODG18632 | In distribution | ||
| 7780360E | In distribution | ||
| SM7217 | In distribution | ||
| SM7370 | In distribution | ||
| G67L0JL45 | In distribution | ||
| 67004800 | In distribution | ||
| G8823DRC | In distribution | ||
| SM7684 | In distribution | ||
| SM7174 | In distribution | ||
| 67006200 | In distribution | ||
| 77827900 | In distribution | ||
| SM7128 | In distribution | ||
| SM7502 | In distribution | ||
| SM7437 | In distribution | ||
| G880IMD | In distribution | ||
| SM7681 | In distribution | ||
| SM7497 | In distribution | ||
| G667657 | In distribution | ||
| G780IMD | In distribution | ||
| G670CH3 | In distribution | ||
| 67027200 | In distribution | ||
| SM7398 | In distribution | ||
| 67018000 | In distribution | ||
| MODG17604 | In distribution | ||
| SM7720 | In distribution | ||
| G670MPAN | In distribution | ||
| G780JCL5 | In distribution | ||
| SM7646 | In distribution | ||
| SM7469 | In distribution | ||
| SM7504 | In distribution | ||
| MODG18776 | In distribution | ||
| SM7206 | In distribution | ||
| G880MPAF | In distribution | ||
| SM7578 | In distribution | ||
| X9835SH | In distribution | ||
| G670ARM1H | In distribution | ||
| SM7421 | In distribution | ||
| MODG18781 | In distribution | ||
| 67018200 | In distribution | ||
| MODG17791 | In distribution | ||
| SM7360 | In distribution | ||
| 67018100 | In distribution | ||
| 4037553M | In distribution | ||
| SM7147 | In distribution | ||
| SM7603 | In distribution | ||
| SM7688 | In distribution | ||
| 67028090 | In distribution | ||
| SM7569 | In distribution | ||
| SM7542 | In distribution | ||
| G7803DRC | In distribution | ||
| G880JL5N | In distribution | ||
| G670JR4D | In distribution | ||
| SM7498 | In distribution | ||
| SM6914 | In distribution | ||
| MODG18641 | In distribution | ||
| 67021255 | In distribution | ||
| G670JL5L | In distribution | ||
| 67007500 | In distribution | ||
| G672MPAF | In distribution | ||
| G882AR1H | In distribution | ||
| 588843E | In distribution | ||
| SM7575 | In distribution | ||
| SM7181 | In distribution | ||
| SM7751 | In distribution | ||
| G880AR2H | In distribution | ||
| SM7489 | In distribution | ||
| SM7655 | In distribution | ||
| SM7428 | In distribution | ||
| SM7313 | In distribution | ||
| SM7323 | In distribution | ||
| 77804800 | In distribution | ||
| SM7368 | In distribution | ||
| SM7185 | In distribution | ||
| SM7637 | In distribution | ||
| 6701100L | In distribution | ||
| SM7679 | In distribution | ||
| SM7547 | In distribution | ||
| 77818000 | In distribution | ||
| SM7417 | In distribution | ||
| SM7369 | In distribution | ||
| 67028055 | In distribution | ||
| SM7033 | In distribution | ||
| SM7438 | In distribution | ||
| SM7405 | In distribution | ||
| SM7379 | In distribution | ||
| SM7143 | In distribution | ||
| MODG17792 | In distribution | ||
| SM7228 | In distribution | ||
| 598949P | In distribution | ||
| SM7511 | In distribution | ||
| 67008255 | In distribution | ||
| 77818100 | In distribution | ||
| SM6864 | In distribution | ||
| G672CAS1F | In distribution | ||
| 6700820L | In distribution | ||
| SM7463 | In distribution | ||
| 4037553H | In distribution | ||
| G672JR25 | In distribution | ||
| SM7636 | In distribution | ||
| MODG17725 | In distribution | ||
| SM7381 | In distribution | ||
| G670JR4N | In distribution | ||
| SM7712 | In distribution | ||
| SM7189 | In distribution | ||
| SM7330 | In distribution | ||
| SM7384 | In distribution | ||
| G672IMH | In distribution | ||
| 67004000 | In distribution | ||
| 511040P | In distribution | ||
| SM7119 | In distribution | ||
| G780XBLAD3 | In distribution | ||
| SM7582 | In distribution | ||
| SM7701 | In distribution | ||
| SM7543 | In distribution | ||
| SM7349 | In distribution | ||
| SM7550 | In distribution | ||
| MODG17683 | In distribution | ||
| SM7130 | In distribution | ||
| SM7150 | In distribution | ||
| 67012200 | In distribution | ||
| 588834E | In distribution | ||
| SM7706 | In distribution | ||
| MODG17606 | In distribution | ||
| SM7348 | In distribution | ||
| 77808300 | In distribution | ||
| G670JR4MOD | In distribution |
Showing 250 of 300 catalogue numbers.
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 |
| 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 |
| Wiseguide™ | Boston Scientific Corporation | 277 |
Showing 12 of 500. All products under Catheter, Percutaneous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K143412 | 2015-01-14 |
| K021593 | 2002-06-13 |
| K003920 | 2001-06-15 |
| K001136 | 2000-04-28 |
| K000715 | 2000-03-31 |
| K992673 | 1999-10-12 |
| K982632 | 1998-08-18 |
| K982770 | 1998-08-18 |
| K972978 | 1997-10-21 |
| K971572 | 1997-07-14 |
| K963962 | 1997-05-07 |
| K965211 | 1997-03-11 |
| K962830 | 1996-10-17 |
| K962362 | 1996-08-08 |
| K952185 | 1995-08-02 |
| K925131 | 1993-05-06 |
| K921311 | 1992-09-09 |
| K915374 | 1992-02-14 |
| K915777 | 1992-02-11 |
| K912777 | 1991-09-20 |
| K862975 | 1986-09-23 |
| K811971 | 1981-08-13 |
Recalls Naming This Product
3 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 |
|---|---|---|---|---|---|---|---|
| Cordis US Corp. | 510(k) number | 2025-02-07 | Class II | Employee error | Catheter manufactured at the incorrect length. | 12 units | |
| Cordis US Corp. | 510(k) number | 2019-02-07 | Class III | Equipment maintenance | Frayed pieces of the mounting card being inside the primary packaging. | 23481 | 2021-11-03 |
| Cordis US Corp. | 510(k) number | 2004-12-07 | Not classified | Other | Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an ‘RDC’ shape rather than the ‘RDC(1)’ shape. The RDC shape has a larger curve. The product was manufactured with the incorrect forming w | 153 units | 2008-11-19 |
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.