TorFlex Transseptal Guiding Sheath
32 catalogue numbers from TF8-32-63-55, listed by Baylis Médicale Cie Inc, under Introducer, Catheter. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
32catalogue numbers in this listing
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 | Baylis Médicale Cie Inc |
|---|---|
| FDA product code | DYB |
| Device type | Introducer, Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1340 |
| Record published | 2016-08-15 |
| Record revised | 2023-12-08 (version 10) |
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 |
| Distribution end date | 2023-02-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TF8-32-63-55 | 63cm 8F TorFlex Transseptal Sheath with 55° curve; 67cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-63-37 | 63cm 8F TorFlex Transseptal Sheath with 37° curve; 67cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-81-55 | 81cm 8F TorFlex Transseptal Sheath with 55° curve; 85cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF85-32-63-37 | 63cm 8.5F TorFlex Transseptal Sheath with 37° curve; 67cm 8.5F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF85-32-63-45 | 63cm 8.5F TorFlex Transseptal Sheath with 45° curve; 67cm 8.5F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-63-45 | 63cm 8F TorFlex Transseptal Sheath with 45° curve; 67cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF85-32-63-135 | 63cm 8.5F TorFlex Transseptal Sheath with 135° curve; 67cm 8.5F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-81-37 | 81cm 8F TorFlex Transseptal Sheath with 37° curve; 85cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-63-135 | 63cm 8F TorFlex Transseptal Sheath with 135° curve; 67cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-63-45 | 63cm 8F TorFlex Transseptal Sheath with 45° curve; 67cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF85-32-81-90 | 81cm 8.5F TorFlex Transseptal Sheath with 90° curve; 85cm 8.5F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-81-45 | 81cm 8F TorFlex Transseptal Sheath with 45° curve; 85cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF85-32-63-90 | 63cm 8.5F TorFlex Transseptal Sheath with 90° curve; 67cm 8.5F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-63-90 | 63cm 8F TorFlex Transseptal Sheath with 90° curve; 67cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-81-90 | 81cm 8F TorFlex Transseptal Sheath with 90° curve; 85cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF85-32-81-135 | 81cm 8.5F TorFlex Transseptal Sheath with 135° curve; 85cm 8.5F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-81-37 | 81cm 8F TorFlex Transseptal Sheath with 37° curve; 85cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-81-135 | 81cm 8F TorFlex Transseptal Sheath with 135° curve; 85cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF85-32-63-45 | 63cm 8.5F TorFlex Transseptal Sheath with 45° curve; 67cm 8.5F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF85-32-81-37 | 81cm 8.5F TorFlex Transseptal Sheath with 37° curve; 85cm 8.5F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-63-90 | 63cm 8F TorFlex Transseptal Sheath with 90° curve; 67cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-81-55 | 81cm 8F TorFlex Transseptal Sheath with 55° curve; 85cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-63-55 | 63cm 8F TorFlex Transseptal Sheath with 55° curve; 67cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF85-32-81-55 | 81cm 8.5F TorFlex Transseptal Sheath with 55° curve; 85cm 8.5F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF85-32-63-55 | 63cm 8.5F TorFlex Transseptal Sheath with 55° curve; 67cm 8.5F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-63-135 | 63cm 8F TorFlex Transseptal Sheath with 135° curve; 67cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-81-135 | 81cm 8F TorFlex Transseptal Sheath with 135° curve; 85cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF85-32-81-45 | 81cm 8.5F TorFlex Transseptal Sheath with 45° curve; 85cm 8.5F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-63-90 | 63cm 8F TorFlex Transseptal Sheath with 90° curve; 67cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-81-90 | 81cm 8F TorFlex Transseptal Sheath with 90° curve; 85cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF85-32-63-55 | 63cm 8.5F TorFlex Transseptal Sheath with 55° curve; 67cm 8.5F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
| TF8-32-81-45 | 81cm 8F TorFlex Transseptal Sheath with 45° curve; 85cm 8F Transseptal Dilator; 180cm J-Tip Guidewire with OD = 0.032 inch; Max Guidewire OD = 0.032 inch | Withdrawn |
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 |
| Super Sheath | Togo Medikit Co., Ltd. | 122 |
Showing 12 of 439. All products under Introducer, Catheter
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.