Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/Set
FDA 510(k) K140110 · Teleflex, Inc.
510(k) numberK140110
Submission
- Device name
- Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/Set
- Applicant
- Teleflex, Inc.
Reading, PA, US - Received
- January 15, 2014
- Decision date
- March 27, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSO – Catheter, Conduction, Anesthetic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5120
- Specialty
- Anesthesiology
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|---|---|---|---|
| K241410 | EDEN ControlCathBSO · Traditional | Jmt Co., Ltd. | 02/13/2025SE |
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| K230603 | Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen…BSO · Traditional | Teleflex Medical | 08/30/2023SE |
| K193664 | SubQKath Catheter and Needle SetBSO · Traditional | Hk Surgical | 09/09/2020SE |
| K200624 | Percutaneous IntroducerBSO · Traditional | Epimed International, Inc. | 04/27/2020SE |
| K191470 | C-CAT Anaesthesia Catheter kitBSO · Traditional | Cimpax Aps | 10/25/2019SE |
| K181782 | Medline Reinforced Epidural CatheterBSO · Traditional | Medline Industries, Inc. | 03/04/2019SE |
| K173541 | EpinautBSO · Traditional | Imedicom Co., Ltd. | 08/24/2018SE |
| K172777 | Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7BSO · Traditional | PAJUNK GmbH Medizintechnologie | 05/03/2018SE |
| K171584 | B. Braun Tear-Away Introducer NeedleBSO · Traditional | B.Braun Medical, Inc. | 12/22/2017SE |
More from B.Braun Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241451 | Rusch Endotracheal Tubes (Reinforced); Rusch Endotracheal Tubes (Safety Clear); Rusch…BTR · Traditional | 02/11/2025SE |
| K153652 | ARROW FlexBlock Continuous Peripheral Nerve Block Catheter Kit/SetCAZ · Traditional | 06/21/2016SE |
| K141940 | Conchasmart ColumnBTT · Traditional | 11/24/2014SE |
| K140556 | Conchasmart Breathing CircuitBTT · Traditional | 09/24/2014SE |
| K131912 | Conchatherm Neptune Heated Humidifier, Comfort Flo Humidification System, Conchasmart…BTT · Traditional | 03/06/2014SE |
| K123974 | Percutaneous Introducer KitDYB · Traditional | 02/21/2013SE |
| K121403 | Continuous Peripheral Nerve Block Catheter Kit and SetCAZ · Special | 06/20/2012SE |
| K103658 | Flextip Plus Closed Tip Epidural CatherterCAZ · Traditional | 05/16/2012SE |
| K861951 | Modified Teleflex Medical Introducer CatheterDYB · Traditional | 06/19/1986SE |
| K860307 | Peel Away & Split Sheath Percu Cath Introducer SetDYB · Traditional | 05/20/1986SE |
Questions and answers
When was Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/Set cleared by the FDA?
Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/Set (K140110) received a 510(k) decision of Substantially Equivalent on March 27, 2015, 436 days after the submission was received.
What is the product code of K140110?
The FDA product code is BSO – Catheter, Conduction, Anesthetic, a Class II (moderate risk) device regulated under 21 CFR 868.5120.