Atlas FDA

8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER

FDA 510(k) clearance K993966 · decided 2000-02-18

Clearance details

K-number
K993966
Device name
8FR. NARROWFLEX UNIVERSAL INTRA-AORTIC BALLOON CATHETER
Applicant
Arrow Intl., Inc.
Decision
Substantially Equivalent
Date received
1999-11-23
Decision date
2000-02-18
Days to decision
87 days
Clearance type
Special
Product code
DSP
Device class
2
Regulation number
870.3535
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Everett, MA, US
Third-party review
No
Expedited review
No

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CARDIOSAVE Intra-Aortic Balloon Pump (K181122)Datascope Corp.2018-05-31
CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump (K172305)Datascope Corp.2017-10-12
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Recalls involving this device

RecordFirmDate
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840- recall (Z-1880-2024)ARROW INTERNATIONAL Inc.2024-06-03