Atlas FDA

IV SET WITH GRADUATED CHAMBER

FDA 510(k) clearance K781744 · decided 1978-12-07

Clearance details

K-number
K781744
Device name
IV SET WITH GRADUATED CHAMBER
Applicant
National Patent Development Corp.
Decision
Substantially Equivalent
Date received
1978-10-20
Decision date
1978-12-07
Days to decision
48 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Burette Set utilized in gravity IV administration sets and pump administration sets utiliz recall (Z-0621-2026)B Braun Medical Inc2025-11-26
Burette Set utilized in gravity IV administration sets and pump administration sets utiliz recall (Z-0622-2026)B Braun Medical Inc2025-11-26
Metriset Burette Set w/Horizon Pump, Ultrasites, 120 in. Item/Catalog number 375150. The p recall (Z-2410-2008)B. Braun Medical, Inc.2008-09-23
Burette Set w/150 ml Burette w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88 i recall (Z-2411-2008)B. Braun Medical, Inc.2008-09-23
Add-On Burette Set with 150 ml burette and Ultrasite Injection Site without automatic shut recall (Z-2412-2008)B. Braun Medical, Inc.2008-09-23
Add-On Burette Set with 150 ml burette 7 Ultrasite Injection Site with automatic shutoff, recall (Z-2413-2008)B. Braun Medical, Inc.2008-09-23
Burette Set w/150 ml burette w/15 um filter & inj site, inj site, with automatic shutoff 8 recall (Z-2414-2008)B. Braun Medical, Inc.2008-09-23