FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Medline Cardiovascular Procedure Kit
K Number: K212258
·
Decision Dec 3, 2021
Classifications
1
FEI Numbers
165
Registration Numbers
165
Same Product Code
109
Applicant Total
59
Review Days
136
Basic Information
- Device Name
- Medline Cardiovascular Procedure Kit
- K Number
- K212258
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medline Industries, Inc.
- Date Received
- July 20, 2021
- Decision Date
- December 3, 2021
- Product Code
- LRO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- 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 |
|---|---|---|---|
| LRO | General Surgery Tray | FDA class 2 | General, Plastic Surgery |
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| K Number | Device Name | ||
|---|---|---|---|
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| K222665 | Medline UNITE® Ankle Fusion Plating System | Jan 25, 2023 | Substantially Equivalent |
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| K220565 | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | Oct 25, 2022 | Substantially Equivalent |
| K213481 | Medline General Surgery Tray | May 24, 2022 | Substantially Equivalent |
| K213068 | Medline Smoke Evacuation Shroud | Jan 3, 2022 | Substantially Equivalent |
| K211612 | Medline UNITE REFLEX Dynamic Discs | Dec 10, 2021 | Substantially Equivalent |
| K211931 | Medline Digital Thermometer Non-Lubricated Probe Sheath | Sep 20, 2021 | Substantially Equivalent |
| K203538 | SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) | Aug 2, 2021 | Substantially Equivalent |
| K211944 | Medline UNITE® Digital Fusion Screw System | Jul 22, 2021 | Substantially Equivalent |