Medical Device Manufacturer · US , Austin , TX

ClearStream Technologies , Ltd. - FDA 510(k) Cleared Devices

7 submissions · 7 cleared · Since 2008

Recent clearances: BANTAM CATHETER (280MM BALLOON LENGTHS), SLEEK OTW PTA CATHETERS, REEFLEX PTA CATHETER

View 7 510(k) Devices ↓
7
Total
7
Cleared
0
Denied

FDA 510(k) Regulatory Record - ClearStream Technologies , Ltd. Cardiovascular ✕

7 devices
1-7 of 7
Cleared Oct 12, 2011
BANTAM CATHETER (280MM BALLOON LENGTHS)
K112335 · DQY
Cardiovascular · 61d
Cleared Dec 01, 2010
SLEEK OTW PTA CATHETERS
K102035 · LIT
Cardiovascular · 135d
Cleared Aug 04, 2010
REEFLEX PTA CATHETER
K101361 · LIT
Cardiovascular · 82d
Cleared Mar 16, 2010
LITEPAC, MODEL 682
K100490 · LIT
Cardiovascular · 25d
Cleared Dec 30, 2009
BANTAM,48XXXXXX, 50XXXXXX
K093139 · LIT
Cardiovascular · 86d
Cleared Mar 02, 2009
REEKROSS FAMILY OR OTW PTA CATHETERS
K083596 · DQY
Cardiovascular · 87d
Cleared Feb 08, 2008
SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS
K072947 · LIT
Cardiovascular · 113d
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