Package for Medi-Trace Physiological Pre
FDA 510(k) K801321 · Graphic Controls Corp.
510(k) numberK801321
Submission
- Device name
- Package for Medi-Trace Physiological Pre
- Applicant
- Graphic Controls Corp.
Mchenry, IL, US - Received
- June 5, 1980
- Decision date
- June 30, 1980
- 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
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 |
More from Cordis US Corp
| 510(k) | Device | Decision |
|---|---|---|
| K981964 | Medi-Trace 4103 Neonatal ElectrodeDRX · Traditional | 11/13/1998SE |
| K983287 | Medi-Trace 1610C Combination Defibrillation, Monitoring and Pacing ElectrodeMKJ · Traditional | 11/05/1998SE |
| K974730 | Softrans Plus Intrauterine Pressure Catheter System (Iup 5000, Softrans Plus Iupc)KXO · Traditional | 07/14/1998SE |
| K980857 | Medi-Trace 1310P Combination Defibrillation, Monitoring & Pacing ElectrodeMKJ · Traditional | 05/12/1998SE |
| K972970 | Medi-Trace 1510M Combination Defibrillation, Monitoring and Pacing ElectrodeMKJ · Traditional | 08/27/1997SE |
| K964387 | Point of Use II Sharps-A-GatorMMK · Traditional | 03/27/1997SE |
| K964279 | Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc)KXO · Traditional | 01/22/1997SE |
| K963151 | Medi-Trace 5700 Resting ECG ElectrodeDRX · Traditional | 11/19/1996SE |
| K963038 | Medi-Trace 3600 Series of ECG Monitoring ElectrodeDRX · Traditional | 11/15/1996SE |
| K960968 | Medi-Trace 200, Medi-Trace 200-30DRX · Traditional | 10/28/1996SE |
Questions and answers
When was Package for Medi-Trace Physiological Pre cleared by the FDA?
Package for Medi-Trace Physiological Pre (K801321) received a 510(k) decision of Substantially Equivalent on June 30, 1980, 25 days after the submission was received.
What is the product code of K801321?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.