FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Zoom 6F Insert Catheters
K Number: K233975
·
Decision Apr 2, 2024
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
17
Review Days
109
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Basic Information
- Device Name
- Zoom 6F Insert Catheters
- K Number
- K233975
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imperative Care, Inc.
- Date Received
- December 15, 2023
- Decision Date
- April 2, 2024
- Product Code
- DQO
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
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Other Clearances by Imperative Care, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252046 | Zoom System (Zoom 4S Catheter) | Oct 30, 2025 | Substantially Equivalent |
| K252057 | Symphony Thrombectomy System and Symphony 16F 82cm Thrombectomy System | Aug 28, 2025 | Substantially Equivalent |
| K244061 | X-Wire Guidewire | Aug 26, 2025 | Substantially Equivalent |
| K243047 | Zoom 7X Catheter; Zoom Aspiration Tubing; Zoom POD Aspiration Tubing | May 28, 2025 | Substantially Equivalent |
| K250775 | Symphony Thrombectomy System; Symphony 16F 82cm Thrombectomy System | May 14, 2025 | Substantially Equivalent |
| K242672 | Zoom System | Jan 14, 2025 | Substantially Equivalent |
| K240948 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support | Jun 6, 2024 | Substantially Equivalent |
| K231168 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform; Zoom 88 Large Distal Platform Support | May 22, 2023 | Substantially Equivalent |
| K220807 | Imperative Care Radial 088 Access System | May 17, 2022 | Substantially Equivalent |
| K212224 | TracStar LDP Large Distal Platform; Zoom 88 Large Distal Platform | Sep 20, 2021 | Substantially Equivalent |