MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT— 510(k) K022735
Substantially EquivalentMicroVention, Inc.
FDA 510(k) clearance K022735 for MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) WITH THE HYDROLINK SYRINGE KIT, Substantially Equivalent on 2002-09-06. Applicant: MicroVention, Inc.. Device class: 2.
Clearance details
- Applicant
- MicroVention, Inc.
- Product code
- Code HCG
- Device class
- Class 2
- Regulation
- 21 CFR 882.5950
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Aliso Viejo, CA, US
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Adverse events under product code HCG
product code HCG- Death
- 50
- Injury
- 801
- Malfunction
- 5,625
- Total
- 6,476
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.