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510(k) K081156 · FPA Set, Administration, Intravascular

CADD MEDICATION CASSETTE RESERVOIR

Applicant	Smiths Medical MD, Inc., St. Paul MN, US
Decision	Substantially Equivalent, Jul 18, 2008
Received	Apr 23, 2008
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K081156

Date	Firm and product	Code	Linked 510(k)
Oct 18, 2024	Smiths Medical ASD Inc. CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 Open, Classified	FPA	None listed
Oct 18, 2024	Smiths Medical ASD Inc. CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24 Open, Classified	FPA	None listed
Oct 18, 2024	Smiths Medical ASD Inc. CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24 Open, Classified	FPA	None listed
Oct 18, 2024	Smiths Medical ASD Inc. CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24 Open, Classified	FPA	None listed
Oct 18, 2024	Smiths Medical ASD Inc. CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24 Open, Classified	FPA	None listed
Oct 18, 2024	Smiths Medical ASD Inc. CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP Open, Classified	FPA	None listed
Oct 18, 2024	Smiths Medical ASD Inc. CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP Open, Classified	FPA	None listed
Oct 18, 2024	Smiths Medical ASD Inc. ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28 Open, Classified	FPA	None listed
Oct 18, 2024	Smiths Medical ASD Inc. ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28 Open, Classified	FPA	None listed
Jan 30, 2023	Smiths Medical ASD Inc. CADD Administration Set, List Numbers: a) REF 21-7308-24, b) REF 21-7309-24, c) REF 21-7310-24, d) REF 21-7308-24JP, e) REF 21-7309-24JP. Computerized Ambulatory Delivery Device Open, Classified	FPA	None listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.