SAM CHEST SEAL WITH VAVLE— 510(k) K102403
Substantially EquivalentSam Medical Products
FDA 510(k) clearance K102403 for SAM CHEST SEAL WITH VAVLE, Substantially Equivalent on 2011-03-03. Applicant: Sam Medical Products. Device class: 1.
Clearance details
- Device name as filed
- SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL
- Applicant
- Sam Medical Products
- Product code
- Code NAD
- Device class
- Class 1
- Regulation
- 21 CFR 878.4020
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilsonville, OR, US
Recent devices under product code NAD
view allMore clearances from Sam Medical Products
view allAdverse events under product code NAD
product code NAD- Injury
- 431
- Malfunction
- 11,935
- Other
- 1
- Total
- 12,367
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 K102403
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 K102403.
Data sourced from openFDA. This site is unofficial and independent of the FDA.