CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT— 510(k) K970638
Substantially EquivalentCardiothoracic Systems, Inc.
FDA 510(k) clearance K970638 for CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT, Substantially Equivalent on 1997-10-30. Applicant: Cardiothoracic Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardiothoracic Systems, 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
- Cupertino, CA, US
Recent devices under product code DXC
view all- K262086 — PreludeSYNC Radial Compression Device
- 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)
More clearances from Cardiothoracic Systems, Inc.
view allAdverse 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.