Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device system, balloon, intra-aortic and control, reprocessed
Regulation Description Intra-aortic balloon and control system.
Definition 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).
Regulation Medical Specialty Cardiovascular
Review Panel Cardiovascular
Product CodeNKO
Premarket Review Office of Cardiovascular Devices (OHT2)
Circulatory Support, Structural and Vascular Devices (DHT2B)
Submission Type PMA
Regulation Number 870.3535
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-