510(k) Report

510(k) · Cleared

Cleared

Cath-Tech Port Implantable Vascular Access System

K880571510(k) TraditionalCleared Mar 4, 198823-day reviewClass II21 CFR 880.5965

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Catheter Technology Corp. · LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

Cleared on Mar 4, 1988 after a 23-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Mar 4, 1988
Review
23 days
Class
Class II
Product code
LJT
Recalls
None
Predicates
0

4 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared2016: 1 descendant cleared2014: 1 descendant cleared1990200020102020
  1. This deviceK880571 Cath-Tech Port Implantable Vascular Access SystemCatheter Technology Corp. · 1988
  2. Descendant · cites it directly · 1 of its ownK991897 Catheter Innovations Implantable PortCatheter Innovations, Inc. · 1999 · Recalled
  3. Descendant · cites it directly · 0 of its ownK153359 BardPort®, SlimPort®, and X-Port® Implanted PortsC.R. Bard, Inc. · 2016
  4. Descendant · cites it directly · 0 of its ownK133335 Powerport Implantable PortC.R. Bard, Inc. · 2014
  5. Descendant · cites it directly · 0 of its ownK993860 Catheter Innovations Implantable PortCatheter Innovations, Inc. · 1999

Most influential descendants

Showing 4 of 4 · See all
  • K991897Catheter Innovations Implantable PortCatheter Innovations, Inc. · 1999 · cites it directly1descendant
  • K153359BardPort®, SlimPort®, and X-Port® Implanted PortsC.R. Bard, Inc. · 2016 · cites it directly0descendants
  • K133335Powerport Implantable PortC.R. Bard, Inc. · 2014 · cites it directly0descendants
  • K993860Catheter Innovations Implantable PortCatheter Innovations, Inc. · 1999 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K880571Cath-Tech Port Implantable Vascular Access SystemCatheter Technology Corp.1988—
+1K991897Catheter Innovations Implantable PortCatheter Innovations, Inc.19999
+1K153359BardPort®, SlimPort®, and X-Port® Implanted PortsC.R. Bard, Inc.2016—
+1K133335Powerport Implantable PortC.R. Bard, Inc.2014—
+1K993860Catheter Innovations Implantable PortCatheter Innovations, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
201410
201610
FIG. 1 — Lineage of K880571, 1988–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LJT? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new LJT device

  1. #1 K251253 PowerPort™ isp Implantable Port; PowerPort™…score 14.9 · 9 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K991897Catheter Innovations Implantable PortCatheter Innovations, Inc.19991
K153359BardPort®, SlimPort®, and X-Port® Implanted PortsC.R. Bard, Inc.20160
K133335Powerport Implantable PortC.R. Bard, Inc.20140
K993860Catheter Innovations Implantable PortCatheter Innovations, Inc.19990

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K991897 (Catheter Innovations, Inc., 1999) has gone furthest, with 1 descendant of its own.

How does its category compare?

All LJT devices

LJT Port & Catheter, Implanted, Subcutaneous, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LJT

2in 2025

2007: 112008: 72009: 22010: 22011: 52012: 22013: 72014: 22015: 42016: 32019: 12020: 12023: 12024: 12025: 22026 (partial year): 1
2007high 11 (2007) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LJT

182in 2016

2007: 85 days median2008: 119 days median2011: 144 days median2013: 150 days median2015: 164 days median2016: 182 days median
2007high 182 (2016) · low 85 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LJT

1in 2022

2007: 12008: 22009: 22010: 192011: 12012: 22015: 12017: 12018: 12019: 72022: 12026 (partial year): 1, 1 Class I
2007high 19 (2010) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · LJT

4,308in 2025

2007: 2082008: 1612009: 1722010: 2072011: 2022012: 1532013: 1412014: 1432015: 1492016: 1352017: 2622018: 8782019: 7652020: 9592021: 1,2852022: 1,3342023: 1,2212024: 1,8962025: 4,308
2007high 4,308 (2025) · low 135 (2016)2025

MAUDE reports naming product code LJT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200711851208
200871192161
20092—2172
20102—19207
201151441202
20122—2153
201371500141
20142—0143
201541641149
201631820135
20170—1262
20180—1878
20191—7765
20201—0959
20210—01,285
20220—11,334
20231—01,221
20241—01,896
20252—04,308
20261—1 (1)—

More from Catheter Technology Corp.

13 FDA decisions under this applicant name. See the company

  • K871080Peripherally Inserted Central Venous CatheterCatheter Technology Corp. · 19871 recall
  • K871998Groshong CV Catheter Repair KitCatheter Technology Corp. · 19871 recall
  • K860256Brawn and Groshong CathetersCatheter Technology Corp. · 19861 recall
  • K842577Cath-Tech Polyurethane Umbilical VessCatheter Technology Corp. · 1985
  • K842147Cath-Tech Cholangiography CatheterCatheter Technology Corp. · 1984

Recent decisions in LJT

The LJT category page

  • K260916FLEXI-PORT™ Power Injectable Implantable PortPortal Access, Inc. · 2026
  • K252478Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Injectable Implantable Port…Bard Access Systems, Inc. · 2025
  • K251253PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M.R.I. ™ Implantable Port…Bard Access Systems, Inc. · 2025
  • K242328PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable PortsBard Access Systems, Inc. · 2024
  • K232737PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp ECG Enabled Implantable…Bard Peripheral Vascular, Inc. · 2023

https://510kreport.com/device/K880571 · printed Nov 4, 2026

Cite this page

510(k) Report. “K880571: Cath-Tech Port Implantable Vascular Access System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K880571

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026