URESIL OCCLUSION BALLOON CATHETER— 510(k) K863559
Substantially EquivalentUresil Corp.
FDA 510(k) clearance K863559 for URESIL OCCLUSION BALLOON CATHETER, Substantially Equivalent on 1986-10-10. Applicant: Uresil Corp.. Device class: 2.
Clearance details
- Applicant
- Uresil Corp.
- Product code
- Code DQT
- Device class
- Class 2
- Regulation
- 21 CFR 870.1370
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Skokie, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.