510(k) K150530
- Device
- Level Sensor, Level Sensor Tape
- Applicant
- Medtronic, Inc
- 510(k) number
- K150530
- Product code
- DTW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-05-08
- Date received
- 2015-03-02
- Regulation
- 870.4340
- Classification name
- Monitor And/or Control, Level Sensing, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Rahul Shah
- Address
- 7611 Northland Dr. Minneapolis MN US 55428 55428
FDA Registration Numbers#
- 3012307300
- 2184009
- 2032112
- 1828100
- 9617604
- 3015431638
Source Documents#
Other 510(k) Records For Product Code DTW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K041558 | STOCKERTIR PURGE CONTROL (APC) SYSTEM | Stockert Instrumente GmbH | 2004-07-02 |
| K992857 | LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 | Rocky Mountain Research, Inc. | 1999-11-10 |
| K955152 | STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER | Stoeckert Instrumente | 1996-02-22 |
| K910599 | CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR | Jtl Medical Corp. | 1993-05-20 |
| K924354 | STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR | Sorin Biomedica, Fiat, USA, Inc. | 1993-02-18 |
| K915337 | CAPIOX LEVEL ALARM | Terumo Medical Corp. | 1992-02-21 |
| K900910 | COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) | Cobe Laboratories, Inc. | 1990-05-22 |
| K900815 | SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL | 3M Company | 1990-05-09 |
| K873206 | MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE | Respiratory Support Products, Inc. | 1987-09-30 |
| K860076 | GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 | Gambro, Inc. | 1986-05-30 |
| K852407 | SENSOR TAPE CAT. NO. ST-45 | American Omni Medical, Inc. | 1985-10-21 |
| K843802 | STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR | Shiley, Inc. | 1984-12-27 |
| K831879 | UNIVERSAL LEVEL SENSOR | 3M Health Care, Sarns | 1983-07-26 |
| K823712 | BEL BLOOD LEVEL DETECTOR | R. Scott Bell | 1983-02-07 |
| K822821 | GAMBRO BLOOD LEVEL DETECTOR LCS 10 | Gambro, Inc. | 1982-10-18 |
Legacy Summary#
summary
FDA Review#
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