STERILE, DISP DOME, INDIVID. PKG.— 510(k) K801239
Substantially EquivalentPacific Domes, Inc.
FDA 510(k) clearance K801239 for STERILE, DISP DOME, INDIVID. PKG., Substantially Equivalent on 1980-07-14. Applicant: Pacific Domes, Inc.. Device class: 2.
Clearance details
- Applicant
- Pacific Domes, Inc.
- Product code
- Code DRS
- Device class
- Class 2
- Regulation
- 21 CFR 870.2850
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code DRS
view all- K254074 — TruPress
- K242909 — FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensors
- K221782 — Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes
- K172458 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
- K163172 — HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
Adverse events under product code DRS
product code DRS- Death
- 8
- Malfunction
- 776
- Total
- 784
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.