JOSTRA HLM TUBING SET
FDA 510(k) clearance K053025 · decided 2005-11-10
Clearance details
- K-number
- K053025
- Device name
- JOSTRA HLM TUBING SET
- Applicant
- Maquet Cardiopulmonary, AG
- Decision
- Substantially Equivalent
- Date received
- 2005-10-27
- Decision date
- 2005-11-10
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- DWE
- Device class
- 2
- Regulation number
- 870.4390
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fairfield, IA, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SMARxT Tubing and Connectors (K233702) | LivaNova USA, Inc. | 2024-08-08 |
| Terumo Pump Tubing (K150542) | Terumo Cardiovascular Systems Corporation | 2015-05-01 |
| AngioVac Circuit (K142607) | Angiodynamics | 2014-12-11 |
| VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT (K092486) | Vortex Medical, Inc. | 2009-08-28 |
| HLM TUBING SET WITH BIOLINE COATING (K080592) | Maquet Cardiopulmonary, AG | 2008-09-11 |
| PUMP TUBING WITH X-COATING (K022857) | Terumo Cardiovascular Systems Corporation | 2002-09-19 |
| PUMP TUBING (K013578) | Terumo Cardiovascular Systems Corp. | 2002-01-22 |
| CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING (K993189) | Terumo Corp. | 2000-03-01 |
| CHEST DRAINAGE TUBING (K993062) | Olson Medical Sales, Inc. | 1999-12-10 |
| COBE SMARXT TUBING AND CONNECTORS (K981613) | Cobe Cardiovascular, Inc. | 1998-10-26 |
| CARDIO-PAK BASIC PUMP PACK (K923231) | Cardio-Med-Associates, Inc. | 1993-07-09 |
| SARNS TEMPERATURE PROBE AND CONNECTOR (K905686) | 3M Health Care, Sarns | 1991-02-25 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990. Used in recall (Z-0490-2018) | Maquet | 2017-12-20 |
| Maquet HLM Tubing Pack; Bioline Coating recall (Z-2401-2010) | Maquet Inc. | 2010-09-12 |