EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135— 510(k) K062126
Substantially EquivalentBiosphere Medical, Inc.
FDA 510(k) clearance K062126 for EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135, Substantially Equivalent on 2006-08-09. Applicant: Biosphere Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Biosphere Medical, Inc.
- Product code
- Code DQO
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rockland, MA, US
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More clearances from Biosphere Medical, Inc.
view allAdverse events under product code DQO
product code DQO- Death
- 35
- Injury
- 993
- Malfunction
- 1,772
- Other
- 5
- Total
- 2,805
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.