Sheath Introducer
FDA 510(k) K150932 · Bioteque Corp.
510(k) numberK150932
Submission
- Device name
- Sheath Introducer
- Applicant
- Bioteque Corp.
Taipei, TW - Received
- April 6, 2015
- Decision date
- July 22, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1310
- Specialty
- Cardiovascular
Other 510(k)s with product code DRE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | Merit Medical Systems, Inc. | 07/27/2026SE |
| K253616 | ProtekDilate Vascular Access KitDRE · Special | Sorin Group Italia S.R.L. | 12/19/2025SE |
| K251325 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 05/29/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | Merit Medical Systems, Inc. | 01/15/2025SE |
| K241720 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 07/12/2024SE |
| K233647 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 12/14/2023SE |
| K232609 | Micro Ace Advanced Micro Access SystemDRE · Special | Merit Medical Systems, Inc. | 09/27/2023SE |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special | Spectranetics, Inc. | 12/15/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | Spectranetics, Inc. | 08/24/2022SE |
| K211679 | Xtractor deviceDRE · Traditional | Xcardia Innovation , Ltd. | 02/17/2022SE |
More from Xcardia Innovation , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GFGE · Traditional | 12/22/2025SE |
| K210419 | BIOTEQ Drainage Catheter BT-PDS-seriesFGE · Traditional | 04/13/2022SE |
| K200103 | BIOTEQ Drainage Catheter Set (One Step Type)FGE · Traditional | 10/09/2020SE |
| K102633 | Bioteq Angiographic CatheterDQO · Traditional | 09/09/2011SE |
| K033862 | Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String LockFGE · Traditional | 02/14/2005SE |
| K033210 | Bioteq Double Pigtail Ureteral Stent SetFAD · Traditional | 12/30/2004SE |
| K032292 | Bioteque A.V. Fistula Needle Set with Safety FlexFOZ · Traditional | 03/22/2004SE |
| K013634 | Bioteque 3 in 1 Hemodialysis Blood Tubing PackFJK · Traditional | 07/09/2002SESK |
| K012526 | Bioteque Scalp Vein SetFPA · Traditional | 09/14/2001SE |
| K002449 | Bioteq I.V. (Intravenous) SetFPA · Traditional | 12/22/2000SE |
Questions and answers
When was Sheath Introducer cleared by the FDA?
Sheath Introducer (K150932) received a 510(k) decision of Substantially Equivalent on July 22, 2016, 473 days after the submission was received.
What is the product code of K150932?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.