Harmac Balloon Wedge Pressure Catheter
FDA 510(k) K963335 · Harmac Medical Products, Inc.
510(k) numberK963335
Submission
- Device name
- Harmac Balloon Wedge Pressure Catheter
- Applicant
- Harmac Medical Products, Inc.
Buffalo, NY, US - Received
- June 28, 1996
- Decision date
- October 16, 1997
- 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 |
|---|---|---|
| K021916 | Harmac Huber Needle Safety Device, H2984001FPA · Traditional | 08/29/2002SE |
| K962829 | Harmac Balloon Angiographic CatheterDQO · Traditional | 10/16/1997SE |
| K962833 | Harmac Temporary Pacing Catheter with BalloonLDF · Traditional | 10/15/1997SE |
| K963336 | Harmac Thermodilution CatheterDYG · Traditional | 08/14/1997SE |
| K963073 | Harmac Bipolar Temporary Pacing Catheter with StyletLDF · Traditional | 08/14/1997SE |
| K963074 | Harmac Quadpolar Mapping Pacing CatheterDRF · Traditional | 06/25/1997SE |
| K950895 | Harmac Extension Infusion SetFPA · Traditional | 09/01/1995SE |
Questions and answers
When was Harmac Balloon Wedge Pressure Catheter cleared by the FDA?
Harmac Balloon Wedge Pressure Catheter (K963335) received a 510(k) decision of Substantially Equivalent on October 16, 1997, 475 days after the submission was received.
What is the product code of K963335?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.