BLOWER/MISTER— 510(k) K983135
Substantially EquivalentCardiothoracic Systems, Inc.
FDA 510(k) clearance K983135 for BLOWER/MISTER, Substantially Equivalent on 1998-11-13. Applicant: Cardiothoracic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiothoracic Systems, Inc.
- Product code
- Code FQH
- Device class
- Class 2
- Regulation
- 21 CFR 880.5475
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cupertino, CA, US
Recent devices under product code FQH
view allMore clearances from Cardiothoracic Systems, Inc.
view allAdverse events under product code FQH
product code FQH- Injury
- 170
- Malfunction
- 2,513
- Other
- 1
- Total
- 2,684
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 K983135
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 K983135.
Data sourced from openFDA. This site is unofficial and independent of the FDA.