Peel Away & Split Sheath Percu Cath Introducer Set
FDA 510(k) K860307 · Teleflex, Inc.
510(k) numberK860307
Submission
- Device name
- Peel Away & Split Sheath Percu Cath Introducer Set
- Applicant
- Teleflex, Inc.
Jeffrey, NH, US - Received
- January 28, 1986
- Decision date
- May 20, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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 |
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| 510(k) | Device | Decision |
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| 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 |
| K103658 | Flextip Plus Closed Tip Epidural CatherterCAZ · Traditional | 05/16/2012SE |
| K861951 | Modified Teleflex Medical Introducer CatheterDYB · Traditional | 06/19/1986SE |
Questions and answers
When was Peel Away & Split Sheath Percu Cath Introducer Set cleared by the FDA?
Peel Away & Split Sheath Percu Cath Introducer Set (K860307) received a 510(k) decision of Substantially Equivalent on May 20, 1986, 112 days after the submission was received.
What is the product code of K860307?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.