Super Sheath
122 catalogue numbers from (15-713B) BT70Z11PGW035, listed by Togo Medikit Co., Ltd., Japan, under Introducer, Catheter. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
122catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Mehow Innovative (Huizhou) Ltd. | Huizhou | Guangdong | Contract manufacturer | 11 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
| Tianjin Ethylene Oxide Sterilization Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 4 |
| Shanghai Microport EP Medtech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Becton Dickinson Medical Devices Co., Ltd. Suzhou | Suzhou | Jiangsu | Contract manufacturer | 2 |
| Cardiocycle Medical(Suzhou) Co., Ltd. | Suzhou | Jiangsu | Complaint-file establishment | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Introducer, Catheter
Record
| Listed by | Togo Medikit Co., Ltd., Japan |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K200379 |
| Record published | 2016-09-16 |
| Record revised | 2024-03-20 (version 11) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at room temperature, in a dry, dark place. |
| Packaging | Box, box of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| (15-713B) BT70Z11PGW035 | In distribution | |
| (39086-23B) BT40Z25PPW035 | In distribution | |
| (16036-07B) BT70Z11PPW038 | In distribution | |
| (16036-06B) BT60Z11PPW038 | In distribution | |
| (39086-16B) BT80Z11PGW035 | In distribution | |
| (16034-04B) BT40Z11PGW035 | In distribution | |
| (15-721B) BT50Z11PPW038 | In distribution | |
| (16035-09B) BT90Z11TGW038 | In distribution | |
| (39086-05B) BT80Z07PGW035 | In distribution | |
| (15-707B) BT70Z07PGW035 | In distribution | |
| (39086-13B) BT50Z11PGW035 | In distribution | |
| (16037-05B) BT50Z25PPW038 | In distribution | |
| (16034-04B) BT40Z11PGW035 | In distribution | |
| (16035-06B) BT60Z11PGW038 | In distribution | |
| (16037-08B) BT80Z25PPW038 | In distribution | |
| (39086-26B) BT70Z25PPW035 | In distribution | |
| (39086-03B) BT60Z07PGW035 | In distribution | |
| (15-714B) BT80Z11PGW035 | In distribution | |
| (39086-13B) BT50Z11PGW035 | In distribution | |
| (16036-05B) BT50Z11PPW038 | In distribution | |
| (39086-24B) BT50Z25PPW035 | In distribution | |
| (39086-28B) BT90Z25TPW035 | In distribution | |
| (15-713B) BT70Z11PGW035 | In distribution | |
| (16037-06B) BT60Z25PPW038 | In distribution | |
| (15-705B) BT50Z07PGW035 | In distribution | |
| (16037-05B) BT50Z25PPW038 | In distribution | |
| (15-704B) BT40Z07PGW035 | In distribution | |
| (39086-02B) BT50Z07PGW035 | In distribution | |
| (16036-08B) BT80Z11PPW038 | In distribution | |
| (16035-06B) BT60Z11PGW038 | In distribution | |
| (39086-32B) BT80Z07PGW038 | In distribution | |
| (16036-09B) BT90Z11TPW038 | In distribution | |
| (15-722B) BT60Z11PPW038 | In distribution | |
| (16036-09B) BT90Z11TPW038 | In distribution | |
| (39086-30B) BT60Z07PGW038 | In distribution | |
| (15-724B) BT80Z11PPW038 | In distribution | |
| (39086-29B) BT50Z07PGW038 | In distribution | |
| (15-715B) BT90Z11TGW035 | In distribution | |
| (15-721B) BT50Z11PPW038 | In distribution | |
| (15-706B) BT60Z07PGW035 | In distribution | |
| (16037-07B) BT70Z25PPW038 | In distribution | |
| (39086-01B) BT40Z07PGW035 | In distribution | |
| (39086-16B) BT80Z11PGW035 | In distribution | |
| (16035-08B) BT80Z11PGW038 | In distribution | |
| (39086-31B) BT70Z07PGW038 | In distribution | |
| (39086-26B) BT70Z25PPW035 | In distribution | |
| (39086-25B) BT60Z25PPW035 | In distribution | |
| (39086-14B) BT60Z11PGW035 | In distribution | |
| (39086-06B) BT90Z07TGW035 | In distribution | |
| (15-712B) BT60Z11PGW035 | In distribution | |
| (15-731B) BT60Z25PPW038 | In distribution | |
| (39086-17B) BT90Z11TGW035 | In distribution | |
| (16035-07B) BT70Z11PGW038 | In distribution | |
| (39086-29B) BT50Z07PGW038 | In distribution | |
| (15-730B) BT50Z25PPW038 | In distribution | |
| (39086-32B) BT80Z07PGW038 | In distribution | |
| (39086-05B) BT80Z07PGW035 | In distribution | |
| (39086-28B) BT90Z25TPW035 | In distribution | |
| (15-733B) BT80Z25PPW038 | In distribution | |
| (15-734B) BT90Z25TPW038 | In distribution | |
| (15-708B) BT80Z07PGW035 | In distribution | |
| (15-708B) BT80Z07PGW035 | In distribution | |
| (39086-23B) BT40Z25PPW035 | In distribution | |
| (39086-17B) BT90Z11TGW035 | In distribution | |
| (16037-09B) BT90Z25TPW038 | In distribution | |
| (15-732B) BT70Z25PPW038 | In distribution | |
| (16037-08B) BT80Z25PPW038 | In distribution | |
| (16037-07B) BT70Z25PPW038 | In distribution | |
| (15-722B) BT60Z11PPW038 | In distribution | |
| (16035-09B) BT90Z11TGW038 | In distribution | |
| (16037-09B) BT90Z25TPW038 | In distribution | |
| (16036-05B) BT50Z11PPW038 | In distribution | |
| (15-714B) BT80Z11PGW035 | In distribution | |
| (39086-25B) BT60Z25PPW035 | In distribution | |
| (15-733B) BT80Z25PPW038 | In distribution | |
| (15-720B) BT40Z11PPW035 | In distribution | |
| (15-715B) BT90Z11TGW035 | In distribution | |
| (16035-05B) BT50Z11PGW038 | In distribution | |
| (39086-27B) BT80Z25PPW035 | In distribution | |
| (15-725B) BT90Z11TPW038 | In distribution | |
| (15-723B) BT70Z11PPW038 | In distribution | |
| (39086-31B) BT70Z07PGW038 | In distribution | |
| (15-734B) BT90Z25TPW038 | In distribution | |
| (16035-05B) BT50Z11PGW038 | In distribution | |
| (16037-06B) BT60Z25PPW038 | In distribution | |
| (39086-33B) BT90Z07TGW038 | In distribution | |
| (16035-07B) BT70Z11PGW038 | In distribution | |
| (39086-03B) BT60Z07PGW035 | In distribution | |
| (39086-27B) BT80Z25PPW035 | In distribution | |
| (15-706B) BT60Z07PGW035 | In distribution | |
| (39086-14B) BT60Z11PGW035 | In distribution | |
| (15-710B) BT40Z11PGW035 | In distribution | |
| (39086-04B) BT70Z07PGW035 | In distribution | |
| (39086-06B) BT90Z07TGW035 | In distribution | |
| (15-705B) BT50Z07PGW035 | In distribution | |
| (15-704B) BT40Z07PGW035 | In distribution | |
| (15-711B) BT50Z11PGW035 | In distribution | |
| (15-725B) BT90Z11TPW038 | In distribution | |
| (16036-04B) BT40Z11PPW035 | In distribution | |
| (39086-15B) BT70Z11PGW035 | In distribution | |
| (15-732B) BT70Z25PPW038 | In distribution | |
| (15-720B) BT40Z11PPW035 | In distribution | |
| (16036-04B) BT40Z11PPW035 | In distribution | |
| (15-724B) BT80Z11PPW038 | In distribution | |
| (15-710B) BT40Z11PGW035 | In distribution | |
| (15-711B) BT50Z11PGW035 | In distribution | |
| (15-712B) BT60Z11PGW035 | In distribution | |
| (15-707B) BT70Z07PGW035 | In distribution | |
| (16035-08B) BT80Z11PGW038 | In distribution | |
| (15-730B) BT50Z25PPW038 | In distribution | |
| (16036-06B) BT60Z11PPW038 | In distribution | |
| (39086-01B) BT40Z07PGW035 | In distribution | |
| (15-723B) BT70Z11PPW038 | In distribution | |
| (39086-15B) BT70Z11PGW035 | In distribution | |
| (39086-30B) BT60Z07PGW038 | In distribution | |
| (15-731B) BT60Z25PPW038 | In distribution | |
| (39086-33B) BT90Z07TGW038 | In distribution | |
| (39086-02B) BT50Z07PGW035 | In distribution | |
| (39086-04B) BT70Z07PGW035 | 7.0Fr Sheath size, 7cm Length, 35 milli-inch Guidewire | In distribution |
| (16036-08B) BT80Z11PPW038 | In distribution | |
| (39086-24B) BT50Z25PPW035 | In distribution | |
| (16036-07B) BT70Z11PPW038 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Demax | Beijing Demax Medical Technology Co., Ltd. | 2,841 |
| Arrow | Teleflex Medical LLC | 1,036 |
| Prelude IDeal™ | Merit Medical Systems, Inc. | 294 |
| Fast-Cath™ | St. Jude Medical | 213 |
| Flexor | Cook Incorporated | 182 |
| Prelude Ease™ | Merit Medical Systems, Inc. | 176 |
| Performer | Cook Incorporated | 174 |
| VSI | Teleflex Medical LLC | 154 |
| Peel-Away | Cook Incorporated | 153 |
| OptiSeal™ | Greatbatch Medical | 127 |
| Brilliant | Lepu Medical Technology (Beijing) Co., Ltd. | 122 |
| Tearaway Introducer Set | Galt Medical Corp. | 96 |
Showing 12 of 439. All products under Introducer, Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K241230 | 2024-09-17 |
| K121504 | 2012-09-27 |
| K060190 | 2006-04-04 |
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.