Atlas FDA

FILTERED EXTENSION SETS

FDA 510(k) clearance K942988 · decided 1995-07-14

Clearance details

K-number
K942988
Device name
FILTERED EXTENSION SETS
Applicant
B. Braun of America, Inc.
Decision
Substantially Equivalent
Date received
1994-06-20
Decision date
1995-07-14
Days to decision
389 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Bethlehem, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ADDitIV utilized in gravity IV administration sets and pump administration sets utilized w recall (Z-0604-2026)B Braun Medical Inc2025-11-26
Caresite utilized in gravity IV administration sets and pump administration sets utilized recall (Z-0626-2026)B Braun Medical Inc2025-11-26
Extension Set utilized in gravity IV administration sets and pump administration sets util recall (Z-0628-2026)B Braun Medical Inc2025-11-26
Extension Set utilized in gravity IV administration sets and pump administration sets util recall (Z-0632-2026)B Braun Medical Inc2025-11-26
Extension Set utilized in gravity IV administration sets and pump administration sets util recall (Z-0633-2026)B Braun Medical Inc2025-11-26
Extension Set utilized in gravity IV administration sets and pump administration sets util recall (Z-0634-2026)B Braun Medical Inc2025-11-26
Extension Set utilized in gravity IV administration sets and pump administration sets util recall (Z-0635-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0653-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0663-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0687-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0692-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0703-2026)B Braun Medical Inc2025-11-26
IV Administration Set utilized in gravity IV administration sets and pump administration s recall (Z-0704-2026)B Braun Medical Inc2025-11-26
Vista set utilized in gravity IV administration sets and pump administration sets utilized recall (Z-0715-2026)B Braun Medical Inc2025-11-26
Outlook set utilized in gravity IV administration sets and pump administration sets utiliz recall (Z-0716-2026)B Braun Medical Inc2025-11-26
Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Acce recall (Z-0091-2023)B. Braun Medical, Inc.2022-10-14
CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 recall (Z-0092-2023)B. Braun Medical, Inc.2022-10-14
STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 3 recall (Z-2022-2014)B. Braun Medical, Inc.2014-07-09
SAFSITE Injection Sites and IV Sets manufactured with SAFSITE Injection Sites. A device us recall (Z-0987-2014)B. Braun Medical, Inc.2014-02-18
Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 1.2um Filter, Pressure limited c recall (Z-0670-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 0.2um Filter, Pressure limited c recall (Z-0671-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, 2 Safesite Inj sites, 0.2um Filter, Pressure limite recall (Z-0672-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, 2 Safesite Inj sites, 0.2um Filter, Pressure limite recall (Z-0673-2010)B. Braun Medical, Inc.2010-01-26
Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj sites, 0.2um Filter, Pressure limit recall (Z-0674-2010)B. Braun Medical, Inc.2010-01-26
Adult Metriset w/Cassette 2 inj sites, LL 120 in. Item/Catalog number 375043. The product recall (Z-2408-2008)B. Braun Medical, Inc.2008-09-23
Gravity and Infusion Pump Intravenous (IV) Sets using the Y-site Ultrasite Valve including recall (Z-0933-03)Braun,B Medical Inc2003-06-12