JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088— 510(k) K123194
Substantially EquivalentNorth American Rescue Products, Inc.
FDA 510(k) clearance K123194 for JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088, Substantially Equivalent on 2013-01-03. Applicant: North American Rescue Products, Inc.. Device class: 2.
Clearance details
- Applicant
- North American Rescue Products, 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
- Greer, SC, US
Recent devices under product code DXC
view all- K262086 — PreludeSYNC Radial Compression Device
- K260105 — Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
- K252772 — Arc Adjustable Radial Cuff Compression Device
- K254060 — Life Saving Tourniquet
- K243627 — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
Adverse 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 →
Recalls naming K123194
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 K123194.
Data sourced from openFDA. This site is unofficial and independent of the FDA.