Solopath Balloon Expandable Transfemoral Introducer
FDA 510(k) K092014 · Onset Medical Corporation
510(k) numberK092014
Submission
- Device name
- Solopath Balloon Expandable Transfemoral Introducer
- Applicant
- Onset Medical Corporation
Irvine, CA, US - Received
- July 6, 2009
- Decision date
- October 8, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K260606 | Echo Large Bore Introducer SheathDYB · Traditional | Echo Medical, LLC | 04/29/2026SE |
| K254248 | Introducer Sheath SetDYB · Traditional | Cardiocycle Medical(Suzhou) Co., Ltd. | 04/23/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | Edwards Lifesciences | 04/17/2026SE |
| K260091 | Aventus Introducer SheathDYB · Traditional | Inquis Medical | 04/13/2026SE |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001)DYB · Traditional | Protaryx Medical, Inc. | 04/10/2026SE |
More from Protaryx Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K152498 | SoloPath Re-Collapsible Access SystemDYB · Traditional | 01/05/2016SE |
| K121404 | Solopath Re-Collapsible Access SystemDYB · Traditional | 05/03/2013SE |
| K112629 | Onset Access Catheter SystemDQY · Traditional | 10/11/2011SE |
| K100819 | The Solopath Balloon Expandable Transfemoral IntroducerDYB · Special | 08/02/2010SE |
| K062852 | Balloon Expandable Transseptal Indroducer, Models BETI-1840 and BETI-1870DYB · Traditional | 02/23/2007SE |
| K061009 | Pathway Balloon Expandable Ureteral Access Sheath, Model BeusEZN · Special | 05/02/2006SE |
| K043254 | Pathway Ureteral Access Sheath, Pathway Expandable Ureteral Access SheathEZN · Traditional | 02/10/2005SE |
Questions and answers
When was Solopath Balloon Expandable Transfemoral Introducer cleared by the FDA?
Solopath Balloon Expandable Transfemoral Introducer (K092014) received a 510(k) decision of Substantially Equivalent on October 8, 2009, 94 days after the submission was received.
What is the product code of K092014?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.