CUSTOM IV SET— 510(k) K830182
Substantially EquivalentCustom Medical, Inc.
FDA 510(k) clearance K830182 for CUSTOM IV SET, Substantially Equivalent on 1983-05-09. Applicant: Custom Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Custom Medical, Inc.
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Custom Medical, Inc.
view allAdverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
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.