FOUNTAIN Infusion Catheter and Occluding Guide Wire— 510(k) K992231
Substantially EquivalentMerit Medical Systems, Inc.
FDA 510(k) clearance K992231 for FOUNTAIN Infusion Catheter and Occluding Guide Wire, Substantially Equivalent on 1999-07-23. Applicant: Merit Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Merit Medical Systems, Inc.
- Product code
- Code QEY
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- South Jordan, UT, US
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More clearances from Merit Medical Systems, Inc.
view allRecalls naming K992231
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K992231.
Data sourced from openFDA. This site is unofficial and independent of the FDA.