Atlas FDA

HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER

FDA 510(k) clearance K033294 · decided 2003-11-26

Clearance details

K-number
K033294
Device name
HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER
Applicant
C.R. Bard, Inc.
Decision
Unknown
Date received
2003-10-14
Decision date
2003-11-26
Days to decision
43 days
Clearance type
Special
Product code
MSD
Device class
2
Regulation number
876.5540
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Salt Lake City, UT, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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

RecordFirmDate
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Pristine Long-Term Hemodialysis Catheter (K203767)C B Bard, Inc.2021-04-02
GlidePath 7.5F Long-Term Dialysis Catheter (K202150)C.R. Bard, Inc.2020-11-18
Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes (K202176)Medical Components, Inc. (dba MedComp)2020-09-03
GlidePath 10F Long-Term Dialysis Catheter (K200627)C.R. Bard, Inc.2020-06-22
GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters (K190527)C. R. Bard2020-03-05
Pristine Hemodialysis Catheter (K182443)Pristine Access Technologies , Ltd.2019-05-31
15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes (K173667)Medical Components, Inc. (dba MedComp)2018-05-17
NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm) (K173805)Marvao Medical Devices, Ltd.2018-02-08

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web (P800002/S035)C.R. Bard, Inc.2026-07-15
Covera™ Vascular Covered Stent (P170042/S015)C.R. Bard, Inc.2026-06-10
Covera™ Vascular Covered Stent (P170042/S014)C.R. Bard, Inc.2025-12-16
Covera™ Vascular Covered Stents (P170042/S013)C.R. Bard, Inc.2025-06-26
Avitene Microfibrillar Collagen Hemostat (P800002/S033)C.R. Bard, Inc.2025-03-13
AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032)C.R. Bard, Inc.2025-02-18
Avitene™ Bulk Flour Cleanroom Expansion (P800002/S031)C.R. Bard, Inc.2024-01-18
Avitene™ Microfibrillar Collagen Hemostat (P800002/S030)C.R. Bard, Inc.2023-10-04