Morse(R) Angiographic Catheters
FDA 510(k) K922552 · North American Instrument Corp.
510(k) numberK922552
Submission
- Device name
- Morse(R) Angiographic Catheters
- Applicant
- North American Instrument Corp.
Glens Falls, NY, US - Received
- May 29, 1992
- Decision date
- March 3, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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|---|---|---|---|
| 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 |
More from Cordis US Corp
| 510(k) | Device | Decision |
|---|---|---|
| K960801 | Selector Angiographic Catheter (Various Models)DQO · Traditional | 03/29/1996SE |
| K955554 | Hemo-ValveDTL · Traditional | 03/04/1996SE |
| K960310 | Epic Introducer SheathDYB · Traditional | 02/07/1996SE |
| K915078 | Morse Hemostatic Catheter Introducer SetDYB · Traditional | 06/10/1992SE |
| K905208 | Morse AnesthesiaFPA · Traditional | 01/10/1992SE |
| K912961 | Morse Vascular Introducer SetDYB · Traditional | 09/11/1991SE |
| K910764 | The Perceptor(Tm) Stand Alone TransducerDRS · Traditional | 04/22/1991SE |
| K903493 | Namic Contrast Savings Delivery SystemIZI · Traditional | 03/26/1991SE |
| K904275 | Morse Balloon Inflation DeviceMAV · Traditional | 01/03/1991SE |
| K903606 | Guidewire Torque Device and Guidewire IntroducerLIT · Traditional | 09/27/1990SE |
Questions and answers
When was Morse(R) Angiographic Catheters cleared by the FDA?
Morse(R) Angiographic Catheters (K922552) received a 510(k) decision of Substantially Equivalent on March 3, 1993, 278 days after the submission was received.
What is the product code of K922552?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.