510(k) K980732
- Device
- 3M CDI QUICK-CELLS WITH HEPARIN TREATMENT
- Applicant
- 3M HEALTH CARE
- 510(k) number
- K980732
- Product code
- DRY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-05-15
- Date received
- 1998-02-25
- Regulation
- 870.4330
- Classification name
- Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DIANA THORSON
- Address
- 1311 Valencia Ave. Tistin CA US 92780 92780
FDA Registration Numbers#
- 3006073153
- 9617601
- 3002807561
- 2029275
- 3019807891
- 3016618143
- 9611109
- 1118880
- 2184009
- 2245590
- 1218950
- 1828100
- 2011171
- 1124841
- 1319639
- 3000126629
- 9680841
- 1928237
- 3002807090
Source Documents#
Other 510(k) Records For Product Code DRY #
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|---|---|---|---|
| K234065 | CDI OneView Monitoring System | Terumo Cardiovascular Systems Corporation | 2024-04-25 |
| K202154 | B-Capta | Livanova Deutschland, GmbH | 2021-04-01 |
| K202557 | Quantum Workstation 12 Elite | Spectrum Medical , Ltd. | 2020-10-02 |
| K182110 | CDI Blood Parameter Monitoring System 550 | Terumo Cardiovascular Systems Corporation | 2018-11-02 |
| K181923 | Quantum Workstation 12.1 | Spectrum Medical , Ltd. | 2018-08-17 |
| K173591 | Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas | Spectrum Medical , Ltd. | 2018-03-28 |
| K163657 | Quantum Workstation | Spectrum Medical , Ltd. | 2017-01-18 |
| K133157 | TRI-OPTIC MEASUREMENT CELL; WITH BALANCE BIOSURFACE, WITH CARMEDA BIOACTIVE SURFACE, WITH TRILLIUM BIOSURFACE, WITH 6 | Medtronic, Inc. | 2014-10-23 |
| K133658 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | Terumo Cardiovascular Systems Corp. | 2014-07-25 |
| K123039 | CDI BLOOD PARAMETER MONITORING SYSTEM 500 | Terumo Cardiovascular Systems Corp. | 2012-11-20 |
| K110957 | M4 MONITOR | Spectrum Medical, Llp | 2011-05-31 |
| K103168 | B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) | Sorin Group Deutschland GmbH | 2011-01-06 |
| K091908 | M3 MONITOR | Spectrum Medical , Ltd. | 2009-07-10 |
| K090147 | BLOOD MONITORING UNIT, MODEL BMU 40 | Maquet Cardiopulmonary, AG | 2009-04-22 |
| K072131 | M3 MONITOR | Spectrum Medical , Ltd. | 2007-08-17 |
Legacy Summary#
summary
FDA Review#
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