510(k) K110218 ยท KTI Bronchoscope Accessory
INSPIRA AIR BALLOON DILATION SYSTEM
| Applicant | Acclarent, Inc., Rmenlo Park CA, US |
| Decision | Substantially Equivalent, Mar 31, 2011 |
| Received | Jan 25, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110218
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2025 | Integra LifeSciences Corp. (NeuroSciences) INSPIRA AIR BALLOON DILATION SYSTEM 10x40, 1 PK. Airway balloon dilation catheter. Open, Classified |
KTI | None listed |
| 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 |
| Mar 1, 2012 | Acclarent, Inc. Inspira AIR Balloon Dilation System,
size 18 x 40;
Manufactured by Acclarent, Inc.
1525-G O'Brien Drive, Menlo Park, CA 94025
Product Usage: 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.