Biocardia Morph Sheath Guide
FDA 510(k) K090999 · Biocardia, Inc.
510(k) numberK090999
Submission
- Device name
- Biocardia Morph Sheath Guide
- Applicant
- Biocardia, Inc.
San Carlos, CA, US - Received
- April 8, 2009
- Decision date
- April 15, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
| 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 |
|---|---|---|
| K242169 | Morph DNA Steerable Introducer SheathDYB · Special | 08/23/2024SE |
| K192774 | BioCardia 8F Morph DNA Deflectable Guide CatheterDQY · Special | 01/07/2020SE |
| K190941 | BioCardia 8.5 F Avance Steerable lntroducerDYB · Traditional | 05/06/2019SE |
| 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 Biocardia Morph Sheath Guide cleared by the FDA?
Biocardia Morph Sheath Guide (K090999) received a 510(k) decision of Substantially Equivalent on April 15, 2009, 7 days after the submission was received.
What is the product code of K090999?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.