Smith Medical Peel-Away Sheath Introducers
FDA 510(k) K112407 · Smiths Medical MD, Inc.
510(k) numberK112407
Submission
- Device name
- Smith Medical Peel-Away Sheath Introducers
- Applicant
- Smiths Medical MD, Inc.
St. Paul, MN, US - Received
- August 22, 2011
- Decision date
- February 9, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K111386 | Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety…FRN · Traditional | 08/29/2011SE |
| K101180 | Gripper Micro Blunt Cannula, Non-Coring Safety Needle (Gripper Micro Needle) Model:…FPA · Traditional | 08/03/2010SE |
| K091181 | Lockbox for Use with Medfusion 3000 Series PumpsMRZ · Traditional | 06/12/2009SE |
| K082783 | Cadd -Solis Medication Safety Software: Administrator and Point-Of-CareMRZ · Traditional | 12/17/2008SE |
| K081156 | Cadd Medication Cassette ReservoirFPA · Traditional | 07/18/2008SE |
| K080743 | Lockbox for Use with Cadd Solis Infusion PumpFRN · Traditional | 04/25/2008SE |
| K072144 | Cadd -Solis Ambulatory Infusion Pump and Cadd -Solis Medication Safety Software -…MEA · Traditional | 03/07/2008SE |
| K072955 | Cadd-Sentry Pro Medication Safety Software-Administrator (21-6275), Point of Care…MRZ · Traditional | 02/13/2008SE |
| K072657 | Power Port-A-Cath, Cath II, and P.A.S. Port T2 Power P.A.C. Implantable Venous Access…LJT · Traditional | 12/14/2007SE |
| K072059 | Gripper Micro NeedleFMI · Traditional | 11/01/2007SE |
Questions and answers
When was Smith Medical Peel-Away Sheath Introducers cleared by the FDA?
Smith Medical Peel-Away Sheath Introducers (K112407) received a 510(k) decision of Substantially Equivalent on February 9, 2012, 171 days after the submission was received.
What is the product code of K112407?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.