Optiseal Enpath Valved PTFE Peelable Introducer
FDA 510(k) K093232 · Great Batch Medical
510(k) numberK093232
Submission
- Device name
- Optiseal Enpath Valved PTFE Peelable Introducer
- Applicant
- Great Batch Medical
Plymouth, MN, US - Received
- October 14, 2009
- Decision date
- March 15, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K261242 | SimplGuideDYB · Traditional | Pendracare | 06/25/2026SE |
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| K261492 | FieldFlex Steerable SheathDYB · Special | CenterPoint Systems, LLC | 06/05/2026SE |
| 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 |
|---|---|---|
| K181855 | RadialSeal Introducer KitDYB · Traditional | 07/26/2018SE |
| K130559 | Mobicath Bi-Directional Guiding SheathDYB · Special | 05/24/2013SE |
| K122832 | Mobicath Transseptal NeedleDRC · Special | 12/19/2012SE |
| K112541 | Z FLEX-270TM Steerable SheathDRA · Traditional | 02/07/2012SE |
| K110051 | Radialsource Transradial Access Introducer KitDYB · Traditional | 02/02/2012SE |
| K111644 | Mobicath Transseptal NeedleDRC · Traditional | 10/03/2011SE |
| K101784 | Mobicath Bi-Directional Guiding Sheath Model 1000182-XXXDYB · Traditional | 11/26/2010SE |
| K102540 | PTFE Portable IntroducerDYB · Special | 11/16/2010SE |
| K093023 | PTFE Peelable IntroducerDYB · Special | 10/29/2009SE |
Questions and answers
When was Optiseal Enpath Valved PTFE Peelable Introducer cleared by the FDA?
Optiseal Enpath Valved PTFE Peelable Introducer (K093232) received a 510(k) decision of Substantially Equivalent on March 15, 2010, 152 days after the submission was received.
What is the product code of K093232?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.