510(k) K820459
- Device
- Viragard/virashield
- Applicant
- TRI-MED, INC.
- 510(k) number
- K820459
- Product code
- DRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-06-16
- Date received
- 1982-02-19
- Regulation
- 870.2850
- Classification name
- Transducer, Blood-Pressure, Extravascular
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3005580113
- 1721676
- 8043969
- 3008693658
- 1319639
- 3031233007
- 3009001657
- 3006891665
- 2246552
- 1928237
- 3006082230
- 3015225571
- 1724474
- 3005595283
- 1423537
- 1721504
- 3040153768
- 1018233
- 3015309643
- 3018094310
- 1422634
- 3015910259
- 3003263092
- 3013596024
- 8043983
- 3009106351
- 1061124
- 3006950086
- 9610816
- 3000126629
- 3033589330
- 3007048453
- 1043214
- 1718873
- 1218950
- 3004832480
- 9616088
- 3004111573
- 3005012805
- 8010042
- 3013319212
- 3009077524
- 8020616
- 2936999
- 3013783488
- 3007603826
- 3007307487
- 3004519921
- 3016701404
- 2648045
- 3012536737
- 1649914
- 3013500228
- 3017636737
- 1054241
- 3011237704
- 2648727
- 1423395
- 3014541700
- 3017987980
- 9612152
- 3010421104
- 2032112
- 1526863
- 9681377
- 3012542015
- 3015173212
- 3008403546
- 3009156722
- 1625425
- 3008496528
- 9610849
- 9616675
- 9615817
- 3016618143
- 1055236
- 9617594
- 2025816
- 3004605321
- 3007836437
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DRS#
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|---|---|---|---|
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| 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 |
| K112203 | COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST | Mirador Biomedical, Inc. | 2011-12-14 |
| 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 |