510(k) K820406
- Device
- Tmo Integrated Circuit System
- Applicant
- TRAVENOL LABORATORIES, S.A.
- 510(k) number
- K820406
- Product code
- KRI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-03-02
- Date received
- 1982-02-12
- Regulation
- 870.4200
- Classification name
- Accessory Equipment, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3006073153
- 8020347
- 3007899424
- 3017540705
- 1646747
- 3011468686
- 3011373951
- 1043214
- 2244478
- 3004215117
- 2916596
- 3004986960
- 9681834
- 3010163695
- 3011216300
- 3016746283
- 1422634
- 1055236
- 1625519
- 3019807891
- 3010402691
- 9611109
- 3009507273
- 3021599320
- 3003752502
- 3003905499
- 3021562887
- 3006849754
- 1643817
- 3004605321
- 1828100
- 3003661577
- 1124841
- 3003306248
- 1218444
- 1319639
- 3010009632
- 1054241
- 9680841
- 8010026
- 8010697
- 2432320
- 2183924
- 3013267343
- 8010762
- 1718850
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KRI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K020365 | 3TM MYOCARDIAL NEEDLE-TEMPERATURE PROBE | 3t Medical Systems, LLC | 2002-05-03 |
| K992635 | INTERFACE MODULE IDDD | Stoeckert Instrumente | 1999-12-20 |
| K990512 | STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS | Stoeckert Instrumente | 1999-11-23 |
| K934782 | AMMEX TUBING ORGANIZER | Ammex Cardiopulmonary Corp. | 1993-11-18 |
| K926233 | CARDIO2 CYCLE | Ergometrix, Inc. | 1993-06-04 |
| K922404 | TUBE GRIP | Georgia Medical Products, Inc. | 1992-11-23 |
| K892856 | NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS | Acacia Laboratories, Inc. | 1989-11-08 |
| K884893 | CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 | American Omni Medical, Inc. | 1989-01-30 |
| K884640 | CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 | American Omni Medical, Inc. | 1989-01-24 |
| K874605 | HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR | Mallinckrodt Critical Care | 1988-02-02 |
| K874925 | CPE 2000 CARDIO PULMONARY ERGOMETER | Medical Graphics Corp. | 1988-01-19 |
| K864890 | STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP | Shiley, Inc. | 1987-02-19 |
| K862510 | STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1 | Shiley, Inc. | 1986-07-17 |
| K862549 | ARTERIAL BLOOD FILTER HOLDER MODEL NO. AF-HE | American Bentley | 1986-07-15 |
| K860298 | STABLELINE | Cardio Metrics, Inc. | 1986-04-02 |