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Company · US

Rand S.R.L.

FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2016. Name variants (Inc, Corp, punctuation) are merged.

4510(k) clearances (0 in 12 months)

2recalls (0 in 12 months)

1recalls that name a 510(k)

Product codes

Code	Device	Records
LGZ	Warmer, Thermal, Infusion Fluid	4
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	2

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Dec 28, 2016	K161613	Hang&Go PAC Rand S.R.L., IT	LGZ
May 8, 2012	K120026	PERFORMER HT/ HANG&GO HT BASIC Rand S.R.L., IT	LGZ
Mar 21, 2007	K070213	PERFORMER CBP SYSTEM Rand S.R.L.	DTQ
Mar 15, 2006	K052555	MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB Rand S.R.L.	DTQ

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Apr 30, 2021	RanD S.r.l. Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter. Terminated	LGZ	None listed
Apr 30, 2021	RanD S.r.l. Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120 Terminated	LGZ	K161613

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