Atlas FDA

HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS

FDA 510(k) clearance K091268 · decided 2009-09-18

Clearance details

K-number
K091268
Device name
HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS
Applicant
Hospira, Inc.
Decision
Substantially Equivalent
Date received
2009-04-30
Decision date
2009-09-18
Days to decision
141 days
Clearance type
Special
Product code
DQE
Device class
2
Regulation number
870.1230
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Lake Forest, IL, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN (K062999)Hospira, Inc.2006-11-03
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OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN (K061159)Hospira, Inc.2006-06-26
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S008)Hospira, Inc.1999-01-29
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S007)Hospira, Inc.1996-09-05
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S006)Hospira, Inc.1996-01-04
DEXTRAN HM 32% HYSTEROSCOPIC DISTENTION MEDIUM (P880028/S003)Hospira, Inc.1995-12-15
DEXTRAN HM 32 (P880028/S002)Hospira, Inc.1990-11-15
DEXTRAN HM 32 (P880028/S001)Hospira, Inc.1989-12-29
DEXTRAN HM 32% (P880028)Hospira, Inc.1989-05-30