ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
FDA 510(k) K202182 · Imperative Care, Inc.
510(k) numberK202182
Submission
- Device name
- ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
- Applicant
- Imperative Care, Inc.
Campbell, CA, US - Received
- August 4, 2020
- Decision date
- September 2, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NRY – Catheter, Thrombus Retriever
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
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| K250775 | Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy SystemQEW · Special | 05/14/2025SE |
| K242672 | Zoom SystemNRY · Traditional | 01/14/2025SE |
| K240948 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal…QJP · Traditional | 06/06/2024SE |
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Questions and answers
When was ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing cleared by the FDA?
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing (K202182) received a 510(k) decision of Substantially Equivalent on September 2, 2020, 29 days after the submission was received.
What is the product code of K202182?
The FDA product code is NRY – Catheter, Thrombus Retriever, a Class II (moderate risk) device regulated under 21 CFR 870.1250.