Armada
Armada 35 LL PTA Catheter 7 mm x 200 mm x 135 cm / Over-The-Wire
14manufacturers in China registered for this device type
86catalogue numbers in this listing
3510(k) clearances naming this product code
3recalls 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 | Abbott Vascular, United States |
|---|---|
| FDA product code | DQY |
| Device type | Catheter, Percutaneous |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-01-15 |
| Record revised | 2020-03-23 (version 10) |
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 |
| Storage | Special storage condition: Store in a dark, dry and cool place. Do not expose to organic solvents, ionizing radiation or ultraviolet light.; Storage environment temperature 59 to 86 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B2030-020 | In distribution | |
| A1020-200 | In distribution | |
| A1020-120 | In distribution | |
| A1030-020 | In distribution | |
| B2080-020 | In distribution | |
| B2070-200 | In distribution | |
| B1120-060 | In distribution | |
| B2060-040 | In distribution | |
| A2025-020 | In distribution | |
| B1050-040 | In distribution | |
| B2080-060 | In distribution | |
| B2090-060 | In distribution | |
| B1050-150 | In distribution | |
| B1090-040 | In distribution | |
| B2030-040 | In distribution | |
| A1025-200 | In distribution | |
| B1050-080 | In distribution | |
| B1090-060 | In distribution | |
| B1070-080 | In distribution | |
| B2060-060 | In distribution | |
| A2040-060 | In distribution | |
| B2060-120 | In distribution | |
| B1070-120 | In distribution | |
| B1070-060 | In distribution | |
| B1030-020 | In distribution | |
| A1040-040 | In distribution | |
| A2025-120 | In distribution | |
| A2030-120 | In distribution | |
| B1050-250 | In distribution | |
| B2120-060 | In distribution | |
| B1040-150 | In distribution | |
| B2060-080 | In distribution | |
| B2050-040 | In distribution | |
| B2060-250 | In distribution | |
| B2060-100 | In distribution | |
| B2040-120 | In distribution | |
| B2050-080 | In distribution | |
| A2015-040 | In distribution | |
| A1025-020 | In distribution | |
| A1025-060 | In distribution | |
| B1070-100 | In distribution | |
| B1040-040 | In distribution | |
| A1015-080 | In distribution | |
| A1030-200 | In distribution | |
| B1040-200 | In distribution | |
| A1040-120 | In distribution | |
| B2080-080 | In distribution | |
| A1015-120 | In distribution | |
| B1140-040 | In distribution | |
| A1040-060 | In distribution | |
| A2020-080 | In distribution | |
| B2040-080 | In distribution | |
| A1020-020 | In distribution | |
| B2100-060 | In distribution | |
| B1090-020 | In distribution | |
| A2020-200 | In distribution | |
| B2140-080 | In distribution | |
| A1020-060 | In distribution | |
| B1070-150 | In distribution | |
| B1050-060 | In distribution | |
| A1040-200 | In distribution | |
| B1090-080 | In distribution | |
| B2070-060 | In distribution | |
| B1140-020 | In distribution | |
| A2015-020 | In distribution | |
| B1040-250 | In distribution | |
| B1060-080 | In distribution | |
| B2040-020 | In distribution | |
| A2030-200 | In distribution | |
| B2050-100 | In distribution | |
| B1070-020 | In distribution | |
| A2020-060 | In distribution | |
| A1015-020 | In distribution | |
| B2050-150 | In distribution | |
| A1025-120 | In distribution | |
| B1040-020 | In distribution | |
| B2070-080 | In distribution | |
| A1015-040 | In distribution | |
| B1030-040 | In distribution | |
| A1040-020 | In distribution | |
| A2020-120 | In distribution | |
| B2140-040 | In distribution | |
| B1050-200 | In distribution | |
| B2090-080 | In distribution | |
| B2050-020 | In distribution | |
| B1060-020 | In distribution |
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 |
|---|---|
| K121352 | 2012-08-15 |
| K014118 | 2002-01-11 |
| K001856 | 2001-03-07 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-01-07 | Not classified | Process control | Five lots of Guide Catheters and Accessory products were processed through Ethylene Oxide (ETO) sterilization with additional plastic material covering the pallet, which is not consistent with validated packaging configuration for ETO ster | 389 units total | 2012-06-26 |
| 2008-03-17 | Not classified | Labeling mix-ups | Mislabeling: The part number on the product label packaging may not match the product. | 7 units | 2011-07-07 |
| 2008-03-17 | Not classified | Labeling mix-ups | Mislabeling: The part number on the product label packaging may not match the product. | 10 units | 2011-07-07 |
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.