510(k) K090660 ยท KTI Bronchoscope Accessory
AIRWAY BALLOON CATHETER INFLATION DEVICE
| Applicant | Acclarent, Inc., Rmenlo Park CA, US |
| Decision | Substantially Equivalent, Jun 12, 2009 |
| Received | Mar 12, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090660
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2013 | Acclarent, Inc. Inspira AIR Balloon Dilation system.
Size 5 x 24 mm, Syringe volume 6-8 cc.
Dilation of airway tree. Terminated |
KTI | None listed |
| Aug 1, 2013 | Acclarent, Inc. Inspira AIR Balloon Dilation system.
Size 7 x 24 mm, Syringe volume 6-8 cc.
Dilation of airway tree. Terminated |
KTI | None listed |
| Aug 1, 2013 | Acclarent, Inc. Inspira AIR Balloon Dilation system.
Size 8.5 x 24 mm, Syringe volume 12 cc.
Dilation of airway tree. Terminated |
KTI | None listed |
| Aug 1, 2013 | Acclarent, Inc. Inspira AIR Balloon Dilation system.
Size 10 x 40 mm, Syringe volume 12 cc.
Dilation of airway tree. Terminated |
KTI | None listed |
| Aug 1, 2013 | Acclarent, Inc. Inspira AIR Balloon Dilation system.
Size 12 x 40 mm, Syringe volume 12 cc.
Dilation of airway tree. Terminated |
KTI | None listed |
| Aug 1, 2013 | Acclarent, Inc. Inspira AIR Balloon Dilation system.
Size 14 x 40 mm, Syringe volume 12 cc.
Dilation of airway tree. Terminated |
KTI | None listed |
| Aug 1, 2013 | Acclarent, Inc. Inspira AIR Balloon Dilation system.
Size 16 x 40 mm, Syringe volume 12 cc.
Dilation of airway tree. Terminated |
KTI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.