ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm— 510(k) K170958
Substantially EquivalentTricol Biomedical, Inc.
FDA 510(k) clearance K170958 for ChitoPulse 9in / 23 cm, ChitoPulse 12in / 30.5 cm, ChitoPulse 15in / 38 cm, Substantially Equivalent on 2017-08-29. Applicant: Tricol Biomedical, Inc.. Device class: 2.
Clearance details
- Applicant
- Tricol Biomedical, 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
- Portland, OR, US
Recent devices under product code DXC
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- 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.