RMI VASCULAR TOURNIQUET KIT— 510(k) K910221
Substantially EquivalentResearch Medical, Inc.
FDA 510(k) clearance K910221 for RMI VASCULAR TOURNIQUET KIT, Substantially Equivalent on 1991-05-16. Applicant: Research Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Research Medical, Inc.
- Product code
- Code DXC
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Recent devices under product code DXC
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- K252772 — Arc Adjustable Radial Cuff Compression Device
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- K243627 — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
More clearances from Research Medical, Inc.
view allAdverse events under product code DXC
product code DXC- Death
- 14
- Injury
- 442
- Malfunction
- 2,209
- Other
- 1
- Total
- 2,666
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.