Intra-Operative Tec Atherectomy System
FDA 510(k) K922970 · Intensive Technology, Inc.
510(k) numberK922970
Submission
- Device name
- Intra-Operative Tec Atherectomy System
- Applicant
- Intensive Technology, Inc.
San Diego, CA, US - Received
- June 19, 1992
- Decision date
- January 13, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MCW – Catheter, Peripheral, Atherectomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4875
- Specialty
- Cardiovascular
Other 510(k)s with product code MCW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260244 | Auryon Atherectomy SystemMCW · Traditional | Eximo Medical | 04/10/2026SE |
| K250723 | FreedomFlow Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere…MCW · Special | Cardio Flow Inc., | 04/25/2025SE |
| K250385 | Turbo-Elite Laser Atherectomy CatheterMCW · Special | Spectranetics | 03/13/2025SE |
| K242757 | Rotarex Atherectomy SystemMCW · Special | Bard Peripheral Vascular, Inc. | 01/30/2025SE |
| K242947 | FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Special | Cardio Flow Inc., | 11/05/2024SE |
| K241553 | Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingMCW · Special | Eximo Medical, Ltd. | 06/27/2024SE |
| K233483 | FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)MCW · Special | Cardio Flow Inc., | 02/15/2024SE |
| K233668 | Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon…MCW · Special | Eximo Medical, Ltd. | 12/15/2023SE |
| K231538 | FreedomFlow Orbital Circumferential Atherectomy SystemMCW · Traditional | Cardio Flow Inc., | 09/27/2023SE |
| K230709 | Auryon Atherectomy SystemMCW · Special | Eximo Medical, Ltd. | 06/09/2023SE |
More from Eximo Medical, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K912664 | Tec Rotating Dual HemovalveDYB · Traditional | 08/24/1992SE |
| K911869 | Ivt Guiding CatheterDQY · Traditional | 10/16/1991SE |
| K903463 | Ivt Introducer SheathDYB · Traditional | 01/03/1991SE |
| K904003 | Hemochron(R) Heparin Response TestKFF · Traditional | 11/29/1990SE |
| K901767 | Modified Ivt Peripheral AtherectomyLIT · Traditional | 06/28/1990SE |
| K896403 | Modified Ivt Peripheral Atherectomy SystemLIT · Traditional | 03/06/1990SE |
| K895903 | Ivt 0.014 Guide WireDQX · Traditional | 01/04/1990SE |
| K892209 | Aptt by Hemochron(R)GFO · Traditional | 06/22/1989SE |
| K890515 | Peripheral Atherectomy SystemDWX · Traditional | 05/23/1989SE |
| K882804 | 0.014 Peripheral Guide WireDQX · Traditional | 10/28/1988SE |
Questions and answers
When was Intra-Operative Tec Atherectomy System cleared by the FDA?
Intra-Operative Tec Atherectomy System (K922970) received a 510(k) decision of Substantially Equivalent on January 13, 1993, 208 days after the submission was received.
What is the product code of K922970?
The FDA product code is MCW – Catheter, Peripheral, Atherectomy, a Class II (moderate risk) device regulated under 21 CFR 870.4875.