PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM— 510(k) K092313
Substantially EquivalentB.Braun Medical, Inc.
FDA 510(k) clearance K092313 for PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM, Substantially Equivalent on 2009-11-04. Applicant: B.Braun Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- B.Braun Medical, Inc.
- Product code
- Code MEA
- 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 MEA
product code MEA- Death
- 19
- Malfunction
- 25,089
- Total
- 25,108
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 K092313
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-2435-2024 — Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor¿ Space Syringe Pump, Infusion Pump, 1 each Component: N/A
- Z-2436-2024 — Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump Kit, 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 K092313.
Data sourced from openFDA. This site is unofficial and independent of the FDA.