510(k) K160747
- Device
- Angel Catheter
- Applicant
- BIO2 MEDICAL, INC.
- 510(k) number
- K160747
- Product code
- PNS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-07-28
- Date received
- 2016-03-18
- Regulation
- 870.3375
- Classification name
- Short-term Intravascular Filter Catheter
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CHRISTOPHER E. BANAS
- Address
- 4670 Table Mountain Dr. Golden CO US 80403 80403
FDA Registration Numbers#
- 3007146453
- 3027260597
- 1721676
Source Documents#
Legacy Summary#
summary
FDA Review#
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