ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN.— 510(k) K870826
Substantially EquivalentShiley, Inc.
FDA 510(k) clearance K870826 for ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN., Substantially Equivalent on 1987-03-23. Applicant: Shiley, Inc.. Device class: 2.
Clearance details
- Applicant
- Shiley, Inc.
- Product code
- Code DQR
- Device class
- Class 2
- Regulation
- 21 CFR 870.1300
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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More clearances from Shiley, Inc.
view allAdverse events under product code DQR
product code DQR- Death
- 2
- Total
- 2
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.