Atlas FDA

AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM

FDA 510(k) clearance K103003 · decided 2010-11-09

Clearance details

K-number
K103003
Device name
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM
Applicant
Aesculap, Inc.
Decision
Substantially Equivalent
Date received
2010-10-12
Decision date
2010-11-09
Days to decision
28 days
Clearance type
Special
Product code
JXG
Device class
2
Regulation number
882.5550
Medical specialty
Neurology
Advisory committee
Neurology
Location
Center Valley, PA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 4. recall (Z-0838-2011)AngioScore Inc.2011-01-04
AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 5. recall (Z-0839-2011)AngioScore Inc.2011-01-04
AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 137 cm, 6. recall (Z-0840-2011)AngioScore Inc.2011-01-04
AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 90 cm, 6.0 recall (Z-0841-2011)AngioScore Inc.2011-01-04
AngioScore, Inc. AngioSculpt PTA Scoring Balloon Catheter; OTW 0.018" Platform, 50 cm, 6.0 recall (Z-0842-2011)AngioScore Inc.2011-01-04