Bipore Accuflex Percutaneous Sheath Introducer
FDA 510(k) K051513 · Bipore, Inc.
510(k) numberK051513
Submission
- Device name
- Bipore Accuflex Percutaneous Sheath Introducer
- Applicant
- Bipore, Inc.
Northvale, NJ, US - Received
- June 2, 2005
- Decision date
- December 7, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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
Other 510(k)s with product code DYB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253526 | NAMIC Dilator and SheathDYB · Traditional | Medline Industries, LP | 07/29/2026SE |
| K261529 | Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/…DYB · Traditional | Hartman Medical Group, LLC | 07/06/2026SE |
| K261242 | SimplGuideDYB · Traditional | Pendracare | 06/25/2026SE |
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | Health Line International Corporation | 06/22/2026SE |
| 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 |
|---|---|---|
| K073434 | Bipore Accuflex Percutaneous Sheath IntroducerDYB · Special | 04/01/2008SE |
| K073318 | Bipore Balloon Dilation CatheterLIT · Special | 01/16/2008SE |
| K041293 | Biopore Balloon Dilation CatheterLIT · Abbreviated | 07/09/2004SE |
| K983650 | Bipore Balloon Dilatation CatheterLIT · Traditional | 02/17/1999SE |
| K973563 | Bipore Balloon Dilatation CatheterLIT · Traditional | 04/01/1998SE |
| K964814 | Bipore Accuflex Percutaneous Sheath IntroducerDYB · Traditional | 05/07/1997SE |
| K961980 | Bipore Balloon Dilatation CatheterLIT · Traditional | 09/12/1996SE |
| K862015 | O.2 Micron Infection Resistant Hydrophobic FilterFIB · Traditional | 07/22/1986SE |
| K844625 | Bipore O.2 Micron Hydrophobic Filter AssemblyKOZ · Traditional | 01/16/1985SE |
Questions and answers
When was Bipore Accuflex Percutaneous Sheath Introducer cleared by the FDA?
Bipore Accuflex Percutaneous Sheath Introducer (K051513) received a 510(k) decision of Substantially Equivalent on December 7, 2005, 188 days after the submission was received.
What is the product code of K051513?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.