8F FlowGate2 Balloon Guide Catheter— 510(k) K153729
Substantially EquivalentConcentric Medical
FDA 510(k) clearance K153729 for 8F FlowGate2 Balloon Guide Catheter, Substantially Equivalent on 2016-01-27. Applicant: Concentric Medical. Device class: 2.
Clearance details
- Applicant
- Concentric Medical
- Product code
- Code DQY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mountain View, CA, US
Recent devices under product code DQY
view allAdverse events under product code DQY
product code DQY- Death
- 464
- Injury
- 4,489
- Malfunction
- 13,721
- Other
- 2
- Total
- 18,676
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 →
Recalls naming K153729
K-number listed on FDA's recall record- Z-1907-2024 — FlowGate2 8F x 85cm, Catalog: 90485 FlowGate2 8F x 95cm, Catalog: 90495
- Z-2569-2018 — FlowGate2 Balloon Guide Catheter, UPN 90485 (8Fx85cm size) and 90495 (8Fx95cm size)
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153729.
Data sourced from openFDA. This site is unofficial and independent of the FDA.