510(k) K070034
K070034 is an FDA 510(k) premarket notification submitted by Ascent Healthcare Solutions for the device "REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES". The FDA issued a decision of Substantially Equivalent on August 17, 2007. The device falls under product code NQG (Stabilizer, Heart, Non-Compression, Reprocessed), a Class I device regulated under 21 CFR 870.4500. Ascent Healthcare Solutions has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 17, 2007
- Date Received
- January 3, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stabilizer, Heart, Non-Compression, Reprocessed
- Device Class
- Class I
- Regulation Number
- 870.4500
- Review Panel
- CV
- Submission Type
The device is used to stabilize, move, lift, and position the heart during cardiovascular surgery. Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).