Arrow
HANDS-OFF(R) Thermodilution Catheter with TwistLock(TM) Cath-Gard(R) and Integral Flushing/Balloon Test Chamber for use with Arrow Percutaneous Sheath Introducer System
1manufacturer
115catalogue numbers in this listing
Who Else Makes It
Registered in Shandong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | DYG |
| Device type | Catheter, Flow Directed |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1240 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K892530 |
| Record published | 2022-03-14 |
| Record revised | 2025-09-24 (version 13) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store at normal room temperature away from direct exposure to light. Prolonged exposure tofluorescent light, sunlight or |
| Packaging | Case of 5, box of 5, box, cage of 5, pack of 5 |
| Sizes | Catheter gauge 4 to 8 Fr; length 50 to 110 cm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN923528 | Catheter Gauge 4 Fr | In distribution |
| IPN000027 | Catheter Gauge 7 Fr | In distribution |
| IPN917232 | Catheter Gauge 4 Fr | In distribution |
| IPN000030 | Catheter Gauge 7.5 Fr | In distribution |
| IPN036076 | Catheter Gauge 7.5 Fr | In distribution |
| IPN000086 | Length 70 cm | In distribution |
| IPN915820 | Length 110 cm | In distribution |
| IPN000103 | Catheter Gauge 7 Fr | In distribution |
| IPN036080 | Length 110 cm | In distribution |
| IPN924821 | Catheter Gauge 5 Fr | In distribution |
| IPN000081 | Length 110 cm | In distribution |
| IPN000082 | Catheter Gauge 4 Fr | In distribution |
| IPN917253 | Catheter Gauge 5 Fr | In distribution |
| IPN000057 | Catheter Gauge 5 Fr | In distribution |
| IPN917225 | Catheter Gauge 6 Fr | In distribution |
| IPN923530 | Length 90 cm | In distribution |
| IPN923527 | Catheter Gauge 6 Fr | In distribution |
| IPN000085 | Length 110 cm | In distribution |
| IPN915244 | Catheter Gauge 6 Fr | In distribution |
| IPN917217 | In distribution | |
| IPN917254 | Length 110 cm | In distribution |
| IPN915251 | Length 50 cm | In distribution |
| IPN000078 | Length 60 cm | In distribution |
| IPN000071 | Catheter Gauge 6 Fr | In distribution |
| IPN000069 | Length 60 cm | In distribution |
| IPN922644 | Length 110 cm | In distribution |
| IPN917236 | Catheter Gauge 6 Fr | In distribution |
| IPN915245 | Length 110 cm | In distribution |
| IPN917218 | Length 110 cm | In distribution |
| IPN915246 | Length 110 cm | In distribution |
| IPN000079 | Catheter Gauge 6 Fr | In distribution |
| IPN917227 | Length 110 cm | In distribution |
| IPN000068 | Length 110 cm | In distribution |
| IPN917220 | Catheter Gauge 4 Fr | In distribution |
| IPN000060 | Catheter Gauge 4 Fr | In distribution |
| IPN915249 | Length 80 cm | In distribution |
| IPN917242 | Length 110 cm | In distribution |
| IPN000055 | Catheter Gauge 6 Fr | In distribution |
| IPN917240 | Catheter Gauge 8 Fr | In distribution |
| IPN917238 | Catheter Gauge 7 Fr | In distribution |
| IPN917231 | Catheter Gauge 7 Fr | In distribution |
| IPN000080 | Catheter Gauge 7 Fr | In distribution |
| IPN917258 | Length 110 cm | In distribution |
| IPN922656 | Catheter Gauge 8 Fr | In distribution |
| IPN000076 | Length 110 cm | In distribution |
| IPN915833 | Length 110 cm | In distribution |
| IPN915250 | Length 60 cm | In distribution |
| IPN000074 | Length 110 cm | In distribution |
| IPN915291 | Catheter Gauge 5 Fr | In distribution |
| IPN000108 | Length 110 cm | In distribution |
| IPN915832 | Catheter Gauge 5 Fr | In distribution |
| IPN000066 | Length 110 cm | In distribution |
| IPN922646 | Catheter Gauge 8 Fr | In distribution |
| IPN917255 | Length 110 cm | In distribution |
| IPN000075 | Length 110 cm | In distribution |
| IPN915815 | Catheter Gauge 7 Fr | In distribution |
| IPN000089 | Catheter Gauge 7 Fr | In distribution |
| IPN000098 | Length 80 cm | In distribution |
| IPN917241 | Catheter Gauge 8 Fr | In distribution |
| IPN917235 | Catheter Gauge 5 Fr | In distribution |
| IPN917243 | Length 80 cm | In distribution |
| IPN917239 | Catheter Gauge 7 Fr | In distribution |
| IPN923524 | Length 60 cm | In distribution |
| IPN000028 | Length 110 cm | In distribution |
| IPN000070 | Catheter Gauge 5 Fr | In distribution |
| IPN000087 | Length 110 cm | In distribution |
| IPN000073 | Catheter Gauge 6 Fr | In distribution |
| IPN915292 | Catheter Gauge 8 Fr | In distribution |
| IPN917233 | Length 50 cm | In distribution |
| IPN915290 | Catheter Gauge 6 Fr | In distribution |
| IPN000054 | Catheter Gauge 5 Fr | In distribution |
| IPN917219 | Catheter Gauge 7 Fr | In distribution |
| IPN915819 | Catheter Gauge 6 Fr | In distribution |
| IPN917237 | Length 90 cm | In distribution |
| IPN917230 | Length 110 cm | In distribution |
| IPN917222 | Length 60 cm | In distribution |
| IPN036079 | Catheter Gauge 7.5 Fr | In distribution |
| IPN917234 | Catheter Gauge 5 Fr | In distribution |
| IPN915822 | Length 110 cm | In distribution |
| IPN000077 | Catheter Gauge 5 Fr | In distribution |
| IPN000072 | Catheter Gauge 6 Fr | In distribution |
| IPN917223 | Length 110 cm | In distribution |
| IPN917244 | Catheter Gauge 7 Fr | In distribution |
| IPN915248 | Catheter Gauge 6 Fr | In distribution |
| IPN917257 | Catheter Gauge 7 Fr | In distribution |
| IPN000099 | Length 110 cm | In distribution |
| IPN000067 | Length 60 cm | In distribution |
| IPN000084 | Length 90 cm | In distribution |
| IPN915247 | Length 110 cm | In distribution |
| IPN915293 | Length 60 cm | In distribution |
| IPN915818 | Length 110 cm | In distribution |
| IPN917229 | Catheter Gauge 8 Fr | In distribution |
| IPN000106 | Length 110 cm | In distribution |
| IPN000056 | Length 110 cm | In distribution |
| IPN000059 | Catheter Gauge 7 Fr | In distribution |
| IPN917256 | Catheter Gauge 6 Fr | In distribution |
| IPN000032 | Length 110 cm | In distribution |
| IPN000034 | Length 110 cm | In distribution |
| IPN917226 | Length 90 cm | In distribution |
| IPN924915 | Catheter Gauge 7 Fr | In distribution |
| IPN923526 | Catheter Gauge 5 Fr | In distribution |
| IPN917224 | Catheter Gauge 6 Fr | In distribution |
| IPN915831 | Catheter Gauge 4 Fr | In distribution |
| IPN917228 | Length 110 cm | In distribution |
| IPN923525 | Catheter Gauge 5 Fr | In distribution |
| IPN036077 | Catheter Gauge 7.5 Fr | In distribution |
| IPN915294 | Catheter Gauge 4 Fr | In distribution |
| IPN917221 | Catheter Gauge 4 Fr | In distribution |
| IPN000031 | Catheter Gauge 7.5 Fr | In distribution |
| IPN923531 | Length 110 cm | In distribution |
| IPN923529 | Catheter Gauge 5 Fr | In distribution |
| IPN915252 | Catheter Gauge 6 Fr | In distribution |
| IPN917246 | Length 110 cm | In distribution |
| IPN000083 | Catheter Gauge 5 Fr | In distribution |
| IPN000102 | Length 110 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Transonic | Transonic Systems, Inc. | 12 |
| Corodyn | B. Braun Medical Inc. | 10 |
| Venos Occlusion Balloon Catheter | Oscor Inc. | 9 |
| Swan-Ganz True Size | Edwards Lifesciences Technology Sarl | 9 |
| Graftmaster | Abbott Vascular | 9 |
| Swan-Ganz | Edwards Lifesciences Technology Sarl | 7 |
| Pruitt Occlusion Catheter | Lemaitre Vascular, Inc. | 6 |
| Swan-Ganz VIP | Edwards Lifesciences Technology Sarl | 3 |
| Swan-Ganz | Becton, Dickinson AND Company | 3 |
| Swan Ganz Catheter | Edwards Lifesciences Technology Sarl | 2 |
| Swan-Ganz Ccombo | Edwards Lifesciences Technology Sarl | 2 |
| Cook | Cook Incorporated | 2 |
Showing 12 of 23. All products under Catheter, Flow Directed
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 |
|---|---|---|---|---|---|---|---|
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-11-15 | Class II | Process control | Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attend | 71 units | 2020-06-19 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2019-11-15 | Class II | Process control | Potential leak in the balloon extension line. If a leak was present and went undetected during pre-use testing as outlined in the IFU, this would cause the balloon to deflate slowly following placement. If the leak went undetected by attend | 1 unit | 2020-06-19 |
| Arrow International, LLC (subsidiary of Teleflex, Incorporated) | 510(k) number | 2013-03-04 | Class II | Labeling Change Control | The product specifications sheet, part of the Instructions for Use (IFU), for the specified product numbers, reference Renografin-76 contrast medium (viscosity of 8.4 centipoise), which is no longer available. Firm is in the process of upd | 99627ea | 2013-12-21 |
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.