FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm
K Number: K153461
·
Decision Dec 11, 2015
Classifications
1
FEI Numbers
228
Registration Numbers
229
Same Product Code
648
Applicant Total
19
Review Days
10
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Basic Information
- Device Name
- Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm
- K Number
- K153461
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maquet Critical Care AB
- Date Received
- December 1, 2015
- Decision Date
- December 11, 2015
- Product Code
- KNT
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Maquet Critical Care AB
| K Number | Device Name | ||
|---|---|---|---|
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| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System | Mar 18, 2020 | Substantially Equivalent |
| K182862 | Servo Guard | Oct 21, 2019 | Substantially Equivalent |
| K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 | Mar 19, 2019 | Substantially Equivalent |
| K160665 | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 | Mar 29, 2017 | Substantially Equivalent |
| K153688 | Edi Catheter ENFit | Mar 2, 2017 | Substantially Equivalent |
| K151814 | SERVO-U Ventilator System, SERVO-n Ventilator System | Dec 21, 2015 | Substantially Equivalent |
| K123149 | SERVO-I VENTILATOR SYSTEM | Jun 20, 2014 | Substantially Equivalent |
| K133958 | FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 | Mar 20, 2014 | Substantially Equivalent |