Evert-O-Cath Catheter
FDA 510(k) K922455 · American Biomaterials Corp.
510(k) numberK922455
Submission
- Device name
- Evert-O-Cath Catheter
- Applicant
- American Biomaterials Corp.
The Woodlands, TX, US - Received
- May 22, 1992
- Decision date
- July 7, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
Other 510(k)s with product code DQO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261455 | Arterial Pressure Monitoring Set/TrayDQO · Traditional | Spectrum Vascular | 06/26/2026SE |
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF…DQO · Traditional | Bioptimal International Pte. , Ltd. | 05/28/2026SE |
| K254278 | Arterial Pressure Monitoring Set/TrayDQO · Special | Spectrum Vascular | 03/25/2026SE |
| K250751 | DualView CatheterDQO · Traditional | Terumo Corporation | 07/17/2025SE |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional | Gentuity, LLC | 01/31/2025SE |
| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/12/2024SE |
| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
| K232536 | Soldier MicrocatheterDQO · Traditional | Embolx, Inc. | 02/23/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
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| K924725 | American Biomed, Inc. Microsurgical InstrumentsMDM · Traditional | 02/05/1993SE |
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| K880371 | Bioglass Dental Endosseous Ridge MaintainerLYC · Traditional | 11/18/1988SE |
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Questions and answers
When was Evert-O-Cath Catheter cleared by the FDA?
Evert-O-Cath Catheter (K922455) received a 510(k) decision of Substantially Equivalent on July 7, 1994, 776 days after the submission was received.
What is the product code of K922455?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.