Conveen Easicath Set
510(k) K973070
Conveen Easicath Set is a Class II device made by Coloplast Corp., cleared under FDA 510(k) K973070 on 6 Nov 1997, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK973070 | Date6 Nov 1997 | StatusActive |
Official records
- FDA 510(k) database K973070
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EZD
- Device class
- Class II
- Regulation
- 21 CFR Part 876.5130
- Advisory committee
- Gastroenterology, Urology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K973070
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| SureCath 28022 | 28022 / 28022 | 05708932021333 | Outer Diameter 2.7 mm; Length 40 cm; Catheter Gauge 8 Fr; Total Volume 700 mL | No longer on the market |
| SureCath 28023 | 28023 / 28023 | 05708932021340 | Length 40 cm; Outer Diameter 3.3 mm; Catheter Gauge 10 Fr; Total Volume 700 mL | No longer on the market |
| SureCath 28024 | 28024 / 28024 | 05708932021357 | Outer Diameter 4 mm; Length 40 cm; Catheter Gauge 12 Fr; Total Volume 700 mL | No longer on the market |
| SureCath 28032 | 28032 / 28032 | 05708932021364 | Outer Diameter 4.7 mm; Length 40 cm; Total Volume 700 mL; Catheter Gauge 14 Fr | No longer on the market |
| SureCath 28032 | 28032 / 28032 | 05708932021371 | Total Volume 700 mL; Outer Diameter 4.7 mm; Length 40 cm; Catheter Gauge 14 Fr | No longer on the market |
| SureCath 28033 | 28033 / 28033 | 05708932640626 | Outer Diameter 5.3 mm; Length 40 cm; Catheter Gauge 16 Fr; Total Volume 700 mL | No longer on the market |
| SureCath 28036 | 28036 / 28036 | 05708932021487 | Outer Diameter 4.7 mm; Catheter Gauge 14 Fr; Length 40 cm; Total Volume 1200 mL | No longer on the market |
| SureCath 28036 | 28036 / 28036 | 05708932618250 | Catheter Gauge 14 Fr; Outer Diameter 4.7 mm; Total Volume 1200 mL; Length 40 cm | No longer on the market |
| SureCath 28037 | 28037 / 28037 | 05708932021500 | Catheter Gauge 16 Fr; Length 40 cm; Outer Diameter 5.3 mm; Total Volume 1200 mL | No longer on the market |
| SureCath 28037 | 28037 / 28037 | 05708932021517 | Total Volume 1200 mL; Length 40 cm; Outer Diameter 6 mm; Catheter Gauge 18 Fr | No longer on the market |
| SureCath Set 28005S | 28005S / 28005S | 05708932021029 | Catheter Gauge 8 Fr; Catheter Working Length 13.4 in; Catheter Working Length 34 cm | On the market |
| SureCath Set 28006S | 28006S / 28006S | 05708932021036 | Catheter Gauge 10 Fr; Catheter Working Length 13.4 in; Catheter Working Length 34 cm | On the market |
| SureCath Set 28007S | 28007S / 28007S | 05708932021043 | Catheter Gauge 12 Fr; Catheter Working Length 34 cm; Catheter Working Length 13.4 in | On the market |
| SureCath Set 28008S | 28008S / 28008S | 05708932021050 | Catheter Gauge 14 Fr; Catheter Working Length 13.4 in; Catheter Working Length 34 cm | On the market |
| SureCath Set 28009 | 28009 / 28009 | 05708932021067 | Catheter Gauge 16 Fr; Catheter Working Length 13.4 in; Catheter Working Length 34 cm | On the market |
| SureCath Set 28009S | 28009S / 28009S | 05708932021074 | Catheter Gauge 16 Fr; Catheter Working Length 13.4 in; Catheter Working Length 34 cm | On the market |
| SureCath Set 28026S | 28026S / 28026S | 05708932021081 | Catheter Gauge 10 Fr; Catheter Working Length 13.4 in; Catheter Working Length 34 cm | On the market |
| SureCath Set 28027 | 28027 / 28027 | 05708932021098 | Catheter Gauge 12 Fr; Catheter Working Length 34 cm; Catheter Working Length 13.4 in | On the market |
| SureCath Set 28027S | 28027S / 28027S | 05708932021104 | Catheter Gauge 12 Fr; Catheter Working Length 34 cm; Catheter Working Length 13.4 in | On the market |
| SureCath Set 28028 | 28028 / 28028 | 05708932021111 | Catheter Gauge 14 Fr; Catheter Working Length 34 cm; Catheter Working Length 13.4 in | On the market |
| SureCath Set 28028S | 28028S / 28028S | 05708932021128 | Catheter Gauge 14 Fr; Catheter Working Length 13.4 in; Catheter Working Length 34 cm | On the market |
| SureCath Set 28029S | 28029S / 28029S | 05708932021135 | Catheter Gauge 16 Fr; Catheter Working Length 34 cm; Catheter Working Length 13.4 in | On the market |
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