510(k) K112203
- Device
- COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST
- Applicant
- MIRADOR BIOMEDICAL, INC.
- 510(k) number
- K112203
- Product code
- DRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-12-14
- Date received
- 2011-08-01
- Regulation
- 870.2850
- Classification name
- Transducer, Blood-pressure, Extravascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JUSTIN HULVERSHORN
- Address
- 2815 Wastlake Ave. Suite 220 Seattle WA US 98102 98102
FDA Registration Numbers#
- 3008403546
- 9615817
- 3032916632
- 1018233
- 3005595283
- 3005580113
- 1625425
- 1061124
- 3013500228
- 3000126629
- 3012528160
- 3012307300
- 9612152
- 3015173212
- 3012536737
- 3004111573
- 1724474
- 3004519921
- 3033589330
- 3007603826
- 1054241
- 9617594
- 2936999
- 3015910259
- 1928237
- 3006891665
- 3007048453
- 3009001657
- 3015309643
- 3002907620
- 1319639
- 3014541700
- 1526863
- 8043983
- 1043214
- 1423395
- 3003263092
- 9616675
- 9616567
- 3008496528
- 3004832480
- 1713468
- 3005012805
- 1055236
- 3017636737
- 1417592
- 3016618143
- 8043969
- 2221819
- 9681377
- 9610849
- 3016761372
- 3007836437
- 3031233007
- 8020616
- 2032112
- 2246552
- 3006082230
- 1423537
- 3012542015
- 8010042
- 3008693658
- 1721504
- 3006950086
- 1721676
- 3004605321
- 1718873
- 3009077524
- 3016701404
- 1218950
- 9610816
- 3011237704
- 3017987980
- 3007307487
- 3010421104
- 3009156722
- 3013596024
- 3018094310
- 3005941719
- 9616088
Source Documents#
Other 510(k) Records For Product Code DRS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors | Edwards Lifesciences, LLC | 2025-03-21 |
| K221782 | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes | Merit Medical Pte. , Ltd. | 2023-03-17 |
| K172458 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit | Smiths Medical Asd, Inc. | 2017-11-09 |
| K163172 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit | Smiths Medical Asd, Inc. | 2017-05-24 |
| K161408 | Compass Cast and MAP | Centurion Medical Products Corporation | 2016-11-22 |
| K152472 | Disposable Pressure Transducer | Zhejiang Haisheng Medical Device Co., Ltd. | 2016-10-31 |
| K152980 | Flo Trac sensor, Volume View sensor | Edwards Lifesciences, LLC | 2016-01-19 |
| K151040 | Art-line Single channel blood pressure system, Art-line Double channel blood pressure system, Art-line Triple channel blood pressure system, IAP Monitoring Set with Disposable Transducer | Biometrix , Ltd. | 2015-09-04 |
| K133624 | COMPASS CT, COMPASS CT PORT | Mirador Biomedical | 2014-04-18 |
| K123095 | MEDLINE BLOOD PRESSURE TRANSDUCER | Medline Industries, Inc. | 2013-05-08 |
| K120624 | ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) | Elcam Medical Acal | 2012-06-08 |
| K102033 | COMBITRANS MONITORING SETS AND ACCESSORIES | B.Braun Melsungen AG | 2011-04-07 |
| K103715 | COMPASS VASCULAR ACCESS / ACCESS PORT / LUMBAR PUNCTURE / INTRACRANIAL PRESSURE | Mirador Biomedical, Inc. | 2011-01-20 |
| K101189 | REAVILLMED PRESSURE MONITORING SYSTEM AND PICC | Reavillmed | 2010-12-22 |
| K101518 | COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE | Mirador Biomedical, Inc. | 2010-10-13 |
Legacy Summary#
summary
FDA Review#
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