CATHETER BALLOON DILATOR PRESSURE GAUGE— 510(k) K895511
Substantially EquivalentArgon Medical Corp.
FDA 510(k) clearance K895511 for CATHETER BALLOON DILATOR PRESSURE GAUGE, Substantially Equivalent on 1990-02-28. Applicant: Argon Medical Corp.. Device class: 2.
Clearance details
- Applicant
- Argon Medical Corp.
- Product code
- Code MAV
- Device class
- Class 2
- Regulation
- 21 CFR 870.1650
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Athens, TX, US
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More clearances from Argon Medical Corp.
view allAdverse events under product code MAV
product code MAV- Malfunction
- 1,433
- Total
- 1,433
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.