Modification to Medamicus Flowguard Peelable Introducer
FDA 510(k) K040150 · Medamicus, Inc.
510(k) numberK040150
Submission
- Device name
- Modification to Medamicus Flowguard Peelable Introducer
- Applicant
- Medamicus, Inc.
Minneapolis, MN, US - Received
- January 23, 2004
- Decision date
- February 18, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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
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| K260606 | Echo Large Bore Introducer SheathDYB · Traditional | Echo Medical, LLC | 04/29/2026SE |
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| 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 |
|---|---|---|
| K030905 | Medamicus Flowguard Peelable IntroducerDYB · Special | 04/09/2003SE |
| K022689 | Modification to Medamicus Axia RSNDYB · Special | 08/23/2002SE |
| K021004 | Valved Peelable IntroducerDYB · Traditional | 06/06/2002SE |
| K020563 | Medamicus Axia RSNDYB · Traditional | 05/21/2002SE |
| K013120 | Percutaneous Introducer Set, Model 042294 and Kit Model 3550-18GZB · Traditional | 01/24/2002SE |
| K011085 | Guidewire Introducer Safety NeedleDYB · Traditional | 07/09/2001SE |
| K000824 | Percutaneous Introducer, Model 10383-XXXDYB · Special | 04/13/2000SE |
| K994097 | Medamicus Epidural IntroducerGZB · Traditional | 03/01/2000SE |
| K990705 | Medamicus Coaxial Introducer Kit, 10330-XXX, Boston Scientific Coaxial Dilator SetDYB · Traditional | 06/28/1999SE |
| K965167 | Percutaneous Venous Introducer 10264DYB · Traditional | 07/25/1997SE |
Questions and answers
When was Modification to Medamicus Flowguard Peelable Introducer cleared by the FDA?
Modification to Medamicus Flowguard Peelable Introducer (K040150) received a 510(k) decision of Substantially Equivalent on February 18, 2004, 26 days after the submission was received.
What is the product code of K040150?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.