AIRWAY BALLOON CATHETER INFLATION DEVICE— 510(k) K090660
Substantially EquivalentAcclarent, Inc.
FDA 510(k) clearance K090660 for AIRWAY BALLOON CATHETER INFLATION DEVICE, Substantially Equivalent on 2009-06-12. Applicant: Acclarent, Inc.. Device class: 2.
Clearance details
- Applicant
- Acclarent, Inc.
- Product code
- Code KTI
- Device class
- Class 2
- Regulation
- 21 CFR 874.4680
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rmenlo Park, CA, US
Recent devices under product code KTI
view allMore clearances from Acclarent, Inc.
view allAdverse events under product code KTI
product code KTI- Malfunction
- 642
- Total
- 642
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 K090660
K-number listed on FDA's recall record- Z-1860-2013 — Inspira AIR Balloon Dilation system. Size 5 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
- Z-1861-2013 — Inspira AIR Balloon Dilation system. Size 7 x 24 mm, Syringe volume 6-8 cc. Dilation of airway tree.
- Z-1862-2013 — Inspira AIR Balloon Dilation system. Size 8.5 x 24 mm, Syringe volume 12 cc. Dilation of airway tree.
- Z-1863-2013 — Inspira AIR Balloon Dilation system. Size 10 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
- Z-1864-2013 — Inspira AIR Balloon Dilation system. Size 12 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
- Z-1865-2013 — Inspira AIR Balloon Dilation system. Size 14 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
- Z-1866-2013 — Inspira AIR Balloon Dilation system. Size 16 x 40 mm, Syringe volume 12 cc. Dilation of airway tree.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K090660.
Data sourced from openFDA. This site is unofficial and independent of the FDA.