FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
K Number: K210996
·
Decision Apr 23, 2021
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
108
Applicant Total
17
Review Days
21
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Basic Information
- Device Name
- ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM Aspiration Tubing
- K Number
- K210996
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imperative Care, Inc.
- Date Received
- April 2, 2021
- Decision Date
- April 23, 2021
- Product Code
- NRY
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | FDA class 2 | Cardiovascular |
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