Morph DNA Steerable Introducer Sheath
FDA 510(k) K242169 · Biocardia
510(k) numberK242169
Submission
- Device name
- Morph DNA Steerable Introducer Sheath
- Applicant
- Biocardia
Sunnyvale, CA, US - Received
- July 24, 2024
- Decision date
- August 23, 2024
- 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
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 |
|---|---|---|
| K192774 | BioCardia 8F Morph DNA Deflectable Guide CatheterDQY · Special | 01/07/2020SE |
| K190941 | BioCardia 8.5 F Avance Steerable lntroducerDYB · Traditional | 05/06/2019SE |
| K090999 | Biocardia Morph Sheath GuideDYB · Traditional | 04/15/2009SE |
| K042553 | Biocardia Morph Universal Deflectable Guide CatheterDQY · Traditional | 02/17/2005SE |
| K012749 | Biocardia Universal Deflectable Guide Catheter, Model 000664DQO · Traditional | 01/24/2002SE |
Questions and answers
When was Morph DNA Steerable Introducer Sheath cleared by the FDA?
Morph DNA Steerable Introducer Sheath (K242169) received a 510(k) decision of Substantially Equivalent on August 23, 2024, 30 days after the submission was received.
What is the product code of K242169?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.