7FR. and 8FR. Triguide Guiding Catheter Add. Curve
FDA 510(k) K910987 · Scimed
510(k) numberK910987
Submission
- Device name
- 7FR. and 8FR. Triguide Guiding Catheter Add. Curve
- Applicant
- Scimed
Minneapolis, MN, US - Received
- March 7, 1991
- Decision date
- May 29, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| 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
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|---|---|---|
| K992142 | Scimed Angiographic CathetersDQO · Special | 07/21/1999SE |
| K953909 | Scimed 6 French Micro-Max Guide CatheterDQY · Traditional | 11/13/1995SE |
| K931584 | Scimed Transport Steerable Guide Wire and Access.DQX · Traditional | 07/01/1993SE |
| K922706 | Scimed SidelinerDQX · Traditional | 12/10/1992SE |
| K915347 | Scimed Viper CatheterLIT · Traditional | 08/17/1992SE |
| K904171 | Scimed Cardiotherm Cardioplegia Delivery SystemDTR · Traditional | 12/06/1990SE |
| K903503 | Scimed Encore Inflation Device, Model SM2500MAV · Traditional | 10/09/1990SE |
Questions and answers
When was 7FR. and 8FR. Triguide Guiding Catheter Add. Curve cleared by the FDA?
7FR. and 8FR. Triguide Guiding Catheter Add. Curve (K910987) received a 510(k) decision of Substantially Equivalent on May 29, 1991, 83 days after the submission was received.
What is the product code of K910987?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.