510(k) Report

510(k) · Decided

Recalled · 2008

Diatek Cannon-Catheter, Model CC5500

K022662510(k) TraditionalDecided May 9, 2003273-day reviewClass II21 CFR 876.5540Recalls 8

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

Arrow Intl., Inc. · MSD Catheter, Hemodialysis, Implanted

Cleared on May 9, 2003 after a 273-day review. The FDA summary names its predicate without a number. It has been recalled 8 times.

Decided
May 9, 2003
Review
273 days
Class
Class II
Product code
MSD
Recalls
8
Predicates
0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K022662Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

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

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

Planning a device in MSD? 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 MSD device

  1. #1 K241581 Hemodialysis Catheterscore 12.4 · 11 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? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—Diatek Cannon-Cath
Named without a submission number
—

What descends from it?

No later submission names this one as a predicate yet.

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

Recalls of this device

DateClassRecallRoot causeReason
Jun 10, 2008Not classifiedZ-2250-2008Device DesignThe tips may not have been adequately welded to the catheter body.
Jun 10, 2008Not classifiedZ-2244-2008Device DesignThe tips may not have been adequately welded to the catheter body.
Jun 10, 2008Not classifiedZ-2246-2008Device DesignThe tips may not have been adequately welded to the catheter body.
Jun 10, 2008Not classifiedZ-2251-2008Device DesignThe tips may not have been adequately welded to the catheter body.
Jun 10, 2008Not classifiedZ-2245-2008Device DesignThe tips may not have been adequately welded to the catheter body.
Jun 10, 2008Not classifiedZ-2247-2008Device DesignThe tips may not have been adequately welded to the catheter body.
Jun 10, 2008Not classifiedZ-2248-2008Device DesignThe tips may not have been adequately welded to the catheter body.
Jun 10, 2008Not classifiedZ-2243-2008Device DesignThe tips may not have been adequately welded to the catheter body.

The 5 latest of 8 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

How does its category compare?

All MSD devices

MSD Catheter, Hemodialysis, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MSD

1in 2025

2007: 72008: 32009: 62010: 42011: 72012: 22013: 52014: 82015: 12016: 22017: 22018: 22019: 12020: 42021: 42025: 1
2007high 8 (2014) · low 0 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MSD

153in 2021

2007: 92 days median2008: 89 days median2009: 81 days median2010: 116 days median2011: 70 days median2013: 105 days median2014: 246 days median2020: 106 days median2021: 153 days median
2007high 246 (2014) · low 70 (2011)2026

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

Recalls per year · MSD

1in 2013

2008: 472009: 492010: 112011: 242013: 12026 (partial year): 4, 4 Class I
2007high 49 (2009) · low 0 (2007)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · MSD

1,054in 2025

2007: 1182008: 1742009: 1732010: 3062011: 2682012: 3672013: 3632014: 5062015: 5502016: 5322017: 4842018: 4632019: 6452020: 4012021: 5232022: 6102023: 5422024: 8412025: 1,054
2007high 1,054 (2025) · low 118 (2007)2025

MAUDE reports naming product code MSD, 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
20077920118
200838947174
200968149173
2010411611306
201177024268
20122—0367
201351051363
201482460506
20151—0550
20162—0532
20172—0484
20182—0463
20191—0645
202041060401
202141530523
20220—0610
20230—0542
20240—0841
20251—01,054
20260—4 (4)—

What is it indicated for?

The Arrow Diatek™ Cannon Catheter™ is indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis. The Cannon Catheter™ is inserted percutaneously and is preferentially placed into the internal jugular vein. Alternately, this catheter may be inserted into subclavian vein, although the jugular vein is the preferred site. Catheters greater than 40 cm are intended for femoral vein insertion. The Cannon Catheter™ is intended for use in adult patients.

Indications for use as stated in the FDA summary.

More from Arrow Intl., Inc.

110 FDA decisions under this applicant name. See the company

  • K100635Arrowgard Evolution Antimicrobial Peripherally Inserted Central Catheter (Picc) Model: S-44041-002…Arrow Intl., Inc. · 2010
  • K093050Arrow Seldinger Arterial Catherization Devices, Models EX Sac 00520Arrow Intl., Inc. · 2009
  • K071491Arrow International, Inc., Surgical DrapesArrow Intl., Inc. · 2007
  • K071998Arrow Echogenic Introducer Needle ComponentArrow Intl., Inc. · 20072 recalls
  • K071111Non-Absorbable Silk SutureArrow Intl., Inc. · 2007

Recent decisions in MSD

The MSD category page

  • K241581Hemodialysis CatheterHaolang Medical USA Corporation · 2025
  • K210461End CapMedical Components Inc (Medcomp) · 2021
  • K203575GlidePath Retro Long-Term Hemodialysis CatheterC.R. Bard, Inc. · 2021
  • K211410GlidePath 13F Long-Term Hemodialysis CatheterBard Peripheral Vascular, Inc. · 2021
  • K203767Pristine Long-Term Hemodialysis CatheterC B Bard, Inc. · 2021

https://510kreport.com/device/K022662 · printed Nov 4, 2026

Cite this page

510(k) Report. “K022662: Diatek Cannon-Catheter, Model CC5500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022662

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026