SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS
FDA 510(k) clearance K810079 · decided 1981-01-30
Clearance details
- K-number
- K810079
- Device name
- SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS
- Applicant
- 3M Health Care, Sarns
- Decision
- Substantially Equivalent
- Date received
- 1981-01-13
- Decision date
- 1981-01-30
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- KRI
- Device class
- 1
- Regulation number
- 870.4200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch 3M Health Care
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE (K020365) | 3t Medical Systems, LLC | 2002-05-03 |
| INTERFACE MODULE IDDD (K992635) | Stoeckert Instrumente | 1999-12-20 |
| STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS (K990512) | Stoeckert Instrumente | 1999-11-23 |
| AMMEX TUBING ORGANIZER (K934782) | Ammex Cardiopulmonary Corp. | 1993-11-18 |
| CARDIO2 CYCLE (K926233) | Ergometrix, Inc. | 1993-06-04 |
| TUBE GRIP (K922404) | Georgia Medical Products, Inc. | 1992-11-23 |
| NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS (K892856) | Acacia Laboratories, Inc. | 1989-11-08 |
| CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 (K884893) | American Omni Medical, Inc. | 1989-01-30 |
| CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 (K884640) | American Omni Medical, Inc. | 1989-01-24 |
| HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (K874605) | Mallinckrodt Critical Care | 1988-02-02 |
| CPE 2000 CARDIO PULMONARY ERGOMETER (K874925) | Medical Graphics Corp. | 1988-01-19 |
| STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP (K864890) | Shiley, Inc. | 1987-02-19 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: recall (Z-0157-2015) | Terumo Cardiovascular Systems Corp | 2014-10-31 |