ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40

FDA 510(k) clearance K040509 · decided 2004-04-19

Clearance details

K-number: K040509
Device name: ALTA LR FIXED TIP CHRONIC HEMODIALYSIS CATHETER, MODELS AL19NH24, AL23NH28, AL27NH32, AL31NH36, AL35NH40
Applicant: Spire Biomedical, Inc.
Decision: Substantially Equivalent
Date received: 2004-02-27
Decision date: 2004-04-19
Days to decision: 52 days
Clearance type: Special
Product code: MSD
Device class: 2
Regulation number: 876.5540
Medical specialty: Gastroenterology, Urology
Advisory committee: Gastroenterology, Urology
Location: Bedford, MA, US
Third-party review: No
Expedited review: No

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Recalls involving this device

Record	Firm	Date
24CM DECATHLON STD KIT Models: DE19SH24 and DE19SH24-K 15.5 Fr Polyurethane twin lumen hem recall (Z-0288-2010)	Spire Biomedical, Inc.	2009-11-17
28CM DECATHLON STD KIT Models: DE23SH28 and DE23SH28-K 15.5 Fr Polyurethane twin lumen hem recall (Z-0289-2010)	Spire Biomedical, Inc.	2009-11-17
32CM DECATHLON STD KIT Models: DE27SH32 and DE27SH32-K 15.5 Fr Polyurethane twin lumen hem recall (Z-0290-2010)	Spire Biomedical, Inc.	2009-11-17
36CM DECATHLON STD KIT Models: DE31SH36 and DE31SH36-K 15.5 Fr Polyurethane twin lumen hem recall (Z-0291-2010)	Spire Biomedical, Inc.	2009-11-17
40CM DECATHLON STD KIT Models: DE35SH40 and DE35SH40-K 15.5 Fr Polyurethane twin lumen hem recall (Z-0292-2010)	Spire Biomedical, Inc.	2009-11-17
55CM DECATHLON STD KIT Models: DE50SH55 and DE50SH55-K 15.5 Fr Polyurethane twin lumen hem recall (Z-0293-2010)	Spire Biomedical, Inc.	2009-11-17
24CM DECATHLON FUNNEL TIP STD KIT Model: DF19SH24 DECATHLON FUNNEL TIP 15.5 Fr polyurethan recall (Z-0294-2010)	Spire Biomedical, Inc.	2009-11-17
28CM DECATHLON FUNNEL TIP STD KIT Model: DF23SH28 DECATHLON FUNNEL TIP 15.5 Fr polyurethan recall (Z-0295-2010)	Spire Biomedical, Inc.	2009-11-17
32CM DECATHLON FUNNEL TIP STD KIT Model: DF27SH32 DECATHLON FUNNEL TIP 15.5 Fr polyurethan recall (Z-0296-2010)	Spire Biomedical, Inc.	2009-11-17
36CM DECATHLON FUNNEL TIP STD KIT Model: DF31SH36 DECATHLON FUNNEL TIP 15.5 Fr polyurethan recall (Z-0297-2010)	Spire Biomedical, Inc.	2009-11-17
40CM DECATHLON FUNNEL TIP STD KIT Model: DF35SH40 DECATHLON FUNNEL TIP 15.5 Fr polyurethan recall (Z-0298-2010)	Spire Biomedical, Inc.	2009-11-17
55CM DECATHLON FUNNEL TIP STD KIT Model: DF50SH55 DECATHLON FUNNEL TIP 15.5 Fr polyurethan recall (Z-0299-2010)	Spire Biomedical, Inc.	2009-11-17
24CM DECATHLON FUNNEL TIP CATHETER Model: DF19SH24-100 DECATHLON FUNNEL TIP - CATHETER ONL recall (Z-0300-2010)	Spire Biomedical, Inc.	2009-11-17
28CM DECATHLON FUNNEL TIP CATHETER Model: DF23SH28-100 DECATHLON FUNNEL TIP - CATHETER ONL recall (Z-0301-2010)	Spire Biomedical, Inc.	2009-11-17
32CM DECATHLON FUNNEL TIP CATHETER Model: DF27SH32-100 DECATHLON FUNNEL TIP - CATHETER ONL recall (Z-0302-2010)	Spire Biomedical, Inc.	2009-11-17
24CM DECATHLON MINI KIT Model: DM19SH24 DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen recall (Z-0303-2010)	Spire Biomedical, Inc.	2009-11-17
28CM DECATHLON MINI KIT Model: DM23SH28 DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen recall (Z-0304-2010)	Spire Biomedical, Inc.	2009-11-17
32CM DECATHLON MINI KIT Model: DM27SH32 DECATHLON MINI KIT 15.5 Fr polyurethane twin lumen recall (Z-0305-2010)	Spire Biomedical, Inc.	2009-11-17
24CM DECATHLON EXCHANGE KIT Model: DX19SH24-XP DECATHLON MINI KIT 15.5 Fr polyurethane twi recall (Z-0306-2010)	Spire Biomedical, Inc.	2009-11-17
28CM DECATHLON EXCHANGE KIT Model: DX23SH28-XP DECATHLON MINI KIT 15.5 Fr polyurethane twi recall (Z-0307-2010)	Spire Biomedical, Inc.	2009-11-17
32CM DECATHLON EXCHANGE KIT Model: DX27SH32-XP DECATHLON MINI KIT 15.5 Fr polyurethane twi recall (Z-0308-2010)	Spire Biomedical, Inc.	2009-11-17
24CM DECATHLON GOLD STD KIT Models: DEC19SH24 and DEC19SH24-K DECATHLON GOLD 15.5 Fr polyu recall (Z-0309-2010)	Spire Biomedical, Inc.	2009-11-17
28CM DECATHLON GOLD STD KIT Models: DEC23SH28 and DEC23SH28-K recall (Z-0310-2010)	Spire Biomedical, Inc.	2009-11-17
32CM DECATHLON GOLD STD KIT Models: DEC27SH32 and DEC27SH32-K DECATHLON GOLD 15.5 Fr polyu recall (Z-0311-2010)	Spire Biomedical, Inc.	2009-11-17
36CM DECATHLON GOLD STD KIT Models: DEC31SH36 and DEC31SH36-K DECATHLON GOLD 15.5 Fr polyu recall (Z-0312-2010)	Spire Biomedical, Inc.	2009-11-17
40CM DECATHLON GOLD STD KIT Models: DEC35SH40 and DEC35SH40-K DECATHLON GOLD 15.5 Fr polyu recall (Z-0313-2010)	Spire Biomedical, Inc.	2009-11-17
55CM DECATHLON GOLD STD KIT Models: DEC50SH55 and DEC50SH55-K DECATHLON GOLD 15.5 Fr polyu recall (Z-0314-2010)	Spire Biomedical, Inc.	2009-11-17
24CM DECATHLON GOLD FUNNEL TIP STD KIT Models: DFC19SH24 and DFC19SH24-K DECATHLON GOLD FU recall (Z-0315-2010)	Spire Biomedical, Inc.	2009-11-17
28CM DECATHLON GOLD FUNNEL TIP STD KIT Models: DFC23SH28 and DFC23SH28-K DECATHLON GOLD FU recall (Z-0316-2010)	Spire Biomedical, Inc.	2009-11-17
32CM DECATHLON GOLD FUNNEL TIP STD KIT Model: DFC27SH32 15.5 Fr polyurethane twin lumen He recall (Z-0317-2010)	Spire Biomedical, Inc.	2009-11-17
24CM ALTA LR STANDARD KIT High Flow Recirculation Catheter Model: AL19SH24 ALTA CATHETER W recall (Z-0318-2010)	Spire Biomedical, Inc.	2009-11-17
28CM ALTA LR STANDARD KIT High Flow Recirculation Model: AL23SH28 ALTA CATHETER WITH SIDE recall (Z-0319-2010)	Spire Biomedical, Inc.	2009-11-17
32CM ALTA LR STANDARD KIT Model: AL27SH32 ALTA CATHETER WITH SIDE HOLES 15.5 Fr polyuretha recall (Z-0320-2010)	Spire Biomedical, Inc.	2009-11-17
36CM ALTA LR STANDARD KIT Model: AL31SH36 ALTA CATHETER WITH SIDE HOLES 15.5 Fr polyuretha recall (Z-0321-2010)	Spire Biomedical, Inc.	2009-11-17
40CM ALTA LR STANDARD KIT Model: AL35SH40 ALTA CATHETER WITH SIDE HOLES 15.5 Fr polyuretha recall (Z-0322-2010)	Spire Biomedical, Inc.	2009-11-17
24CM ALTA LR STANDARD KIT Model: AL19NH24 ALTA CATHETER WITH NO SIDE HOLES 15.5 Fr polyure recall (Z-0323-2010)	Spire Biomedical, Inc.	2009-11-17
28CM ALTA LR STANDARD KIT Model: AL23NH28 ALTA CATHETER WITH NO SIDE HOLES 15.5 Fr polyure recall (Z-0324-2010)	Spire Biomedical, Inc.	2009-11-17
32CM ALTA LR STANDARD KIT Model: AL27NH32 ALTA CATHETER WITH NO SIDE HOLES 15.5 Fr polyure recall (Z-0325-2010)	Spire Biomedical, Inc.	2009-11-17
36CM ALTA LR STANDARD KIT Model: AL31NH36 ALTA CATHETER WITH NO SIDE HOLES 15.5 Fr polyure recall (Z-0326-2010)	Spire Biomedical, Inc.	2009-11-17
24CM ALTA EXCHANGE KIT Model: AL19SH24-XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lume recall (Z-0327-2010)	Spire Biomedical, Inc.	2009-11-17
28CM ALTA EXCHANGE KIT Model: AL23SH28 XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lume recall (Z-0328-2010)	Spire Biomedical, Inc.	2009-11-17
32CM ALTA EXCHANGE Model: AL27SH32 XP ALTA EXCHANGE KIT 15.5 Fr polyurethane twin lumen fi recall (Z-0329-2010)	Spire Biomedical, Inc.	2009-11-17
24CM ALTA LR GOLD STD KIT Model: ALC19SH24 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed recall (Z-0330-2010)	Spire Biomedical, Inc.	2009-11-17
28CM ALTA LR GOLD STD KIT Model: ALC23SH28 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed recall (Z-0331-2010)	Spire Biomedical, Inc.	2009-11-17
32CM ALTA LR GOLD STD KIT Model: ALC27SH32 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed recall (Z-0332-2010)	Spire Biomedical, Inc.	2009-11-17
36CM ALTA LR GOLD STD KIT Model: ALC31SH36 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed recall (Z-0333-2010)	Spire Biomedical, Inc.	2009-11-17
40CM ALTA LR GOLD STD KIT Model: ALC35SH40 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed recall (Z-0334-2010)	Spire Biomedical, Inc.	2009-11-17
55CM ALTA LR GOLD STD KIT Model: ALC50SH55 ALTA GOLD 15.5 Fr polyurethane twin lumen fixed recall (Z-0335-2010)	Spire Biomedical, Inc.	2009-11-17