Flextip Plus Closed Tip Epidural Catherter
FDA 510(k) K103658 · Teleflex, Inc.
510(k) numberK103658
Submission
- Device name
- Flextip Plus Closed Tip Epidural Catherter
- Applicant
- Teleflex, Inc.
Reading, PA, US - Received
- December 15, 2010
- Decision date
- May 16, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAZ – Anesthesia Conduction Kit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5140
- Specialty
- Anesthesiology
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
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| K161075 | Arrow Epidural Catheter KitCAZ · Traditional | Teleflexmedical, Inc. | 10/04/2016SE |
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| K143581 | Arrow Epidural Catheter KitCAZ · Traditional | Teleflexmedical, Inc. | 06/26/2015SE |
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More from Smiths Medical Asd, Inc.
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| 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 |
| K140110 | Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/SetBSO · Traditional | 03/27/2015SE |
| 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 |
| 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 Closed Tip Epidural Catherter cleared by the FDA?
Flextip Plus Closed Tip Epidural Catherter (K103658) received a 510(k) decision of Substantially Equivalent on May 16, 2012, 518 days after the submission was received.
What is the product code of K103658?
The FDA product code is CAZ – Anesthesia Conduction Kit, a Class II (moderate risk) device regulated under 21 CFR 868.5140.