Perfusor® Space Syringe Infusion Pump System— 510(k) K172831
Substantially EquivalentB.Braun Medical, Inc.
FDA 510(k) clearance K172831 for Perfusor® Space Syringe Infusion Pump System, Substantially Equivalent on 2018-06-12. Applicant: B.Braun Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- B.Braun Medical, Inc.
- Product code
- Code FRN
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allentown, PA, US
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More clearances from B.Braun Medical, Inc.
view allAdverse events under product code FRN
product code FRN- Death
- 540
- Injury
- 6,178
- Malfunction
- 1,464,165
- Other
- 52
- Total
- 1,470,935
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K172831
K-number listed on FDA's recall record- Z-2433-2024 — Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump, 1 each Component: N/A
- Z-2434-2024 — Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Product Description: Perfusor Space Syringe Pump, Infusion Pump, 1 each Component: N/A
- Z-2437-2024 — Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perfusor Space Syringe Pump, Non-Wireless, Infusion Pump, 1 each Component: N/A
- Z-0819-2022 — PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172831.
Data sourced from openFDA. This site is unofficial and independent of the FDA.