510(k) Report

510(k) · Cleared

Cleared

Mewissen Catheter

K904788510(k) TraditionalCleared Dec 17, 199055-day reviewClass II21 CFR 870.1200

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

Boston Scientific Corp · DQO Catheter, Intravascular, Diagnostic

Cleared on Dec 17, 1990 after a 55-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 103 devices in its family, counting itself, have a Class I recall. 102 later devices descend from it.

Decided
Dec 17, 1990
Review
55 days
Class
Class II
Product code
DQO
Recalls
None
Predicates
0

102 later devices descend from it, 2 citing it directly. 2 of the 103 devices in this family, counting this one, have a Class I recall.

Descendants, by year cleared 1998: 2 descendants cleared2004: 7 descendants cleared2008: 8 descendants cleared1999: 2 descendants cleared2020: 7 descendants cleared2003: 5 descendants cleared2005: 10 descendants cleared2016: 5 descendants cleared2002: 3 descendants cleared2019: 5 descendants cleared2014: 2 descendants cleared2006: 7 descendants cleared2007: 7 descendants cleared, 1 with a Class I recall12012: 2 descendants cleared2022: 3 descendants cleared2018: 3 descendants cleared2023: 4 descendants cleared2024: 5 descendants cleared2013: 1 descendant cleared, 1 with a Class I recall12026: 7 descendants cleared2025: 3 descendants cleared2017: 1 descendant cleared2011: 1 descendant cleared2021: 2 descendants cleared1990200020102020
  1. This deviceK904788 Mewissen CatheterBoston Scientific Corp · 1990
  2. Descendant · cites it directly · 101 of its ownK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
  3. Descendant · 2 generations on · 95 of its ownK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
  4. Descendant · 3 generations on · 75 of its ownK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
  5. Descendant · 4 generations on · 57 of its ownK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
  6. Descendant · 4 generations on · 56 of its ownK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled

Showing 5 of 102 descendants. See all descendants

Descendants cleared per year

1998: 21999: 22002: 32003: 52004: 72005: 102006: 72007: 72008: 82011: 12012: 22013: 12014: 22016: 52017: 12018: 32019: 52020: 72021: 22022: 32023: 42024: 52025: 32026: 7
1998high 10 (2005) · low 0 (2000)2026

Class I recalls in this family

  • K071664 Trellis-6 Peripheral Infusion System7 generations on · 2007
  • K130904 Trellis-8 Peripheral Infusion System7 generations on · 2013

Most influential descendants

Showing 5 of 102 · See all
  • K974067Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · cites it directly101descendants
  • K981417Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998 · 2 generations on95descendants
  • K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion…Bacchus Vascular, Inc. · 2002 · 3 generations on75descendants
  • K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM…Bacchus Vascular, Inc. · 2002 · 4 generations on57descendants
  • K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)Bacchus Vascular, Inc. · 2002 · 4 generations on56descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K904788Mewissen CatheterBoston Scientific Corp1990—
+1K974067Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc.199823
+2K981417Squirt Fluid Delivery SystemMerit Medical Systems, Inc.1998—
+3K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM…Bacchus Vascular, Inc.2002—
+4K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM…Bacchus Vascular, Inc.20021
+4K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc.20021

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199820
199920
200230
200350
200470
2005100
200670
200771
200880
201110
201220
201311
201420
201650
201710
201830
201950
202070
202120
202230
202340
202450
202530
202670
FIG. 1 — Lineage of K904788, 1990–2026Source: 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.

2 devices in this family have a Class I recall. 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 DQO device

  1. #1 K254278 Arterial Pressure Monitoring Set/Trayscore 14.4 · 2 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? (102)

See all 102

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

NumberDeviceApplicantDecidedDescendants
K974067Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc.1998101
K033569Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathFlowmedica, Inc.20041

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K071664Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc. · 2007 · 7 generations on · ◆ in the 2007 descendants bar of FIG. 11 Class I recall
  • K130904Trellis-8 Peripheral Infusion SystemCovidien · 2013 · 7 generations on · ◆ in the 2013 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K974067 (Merit Medical Systems, Inc., 1998) has gone furthest, with 101 descendants of its own.

How does its category compare?

All DQO devices

DQO Catheter, Intravascular, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQO

2in 2025

2007: 82008: 32009: 82010: 72011: 62012: 152013: 22014: 32015: 102016: 42017: 102018: 102019: 62020: 32021: 12022: 42023: 42024: 42025: 22026 (partial year): 3
2007high 15 (2012) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQO

148in 2024

2007: 106 days median2008: 80 days median2009: 58 days median2010: 137 days median2011: 74 days median2012: 94 days median2014: 109 days median2015: 209 days median2016: 89 days median2017: 176 days median2018: 234 days median2019: 113 days median2020: 30 days median2022: 181 days median2023: 73 days median2024: 148 days median2026 (partial year): 85 days median
2007high 234 (2018) · low 30 (2020)2026

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

Recalls per year · DQO

1in 2023

2007: 142008: 42009: 72010: 112011: 72012: 22013: 12015: 1, 1 Class I2016: 2, 1 Class I2017: 12018: 22019: 712020: 4, 4 Class I2022: 12023: 1, 1 Class I2026 (partial year): 24, 4 Class I
2007high 71 (2019) · low 0 (2014)2026

Class I (11 since 2007) Class II/III not classified

Adverse event reports per year · DQO

656in 2025

2007: 5642008: 7262009: 9332010: 5562011: 6252012: 5322013: 7532014: 6012015: 6282016: 6142017: 8732018: 7772019: 3862020: 3122021: 3382022: 3792023: 3912024: 5112025: 656
2007high 933 (2009) · low 312 (2020)2025

MAUDE reports naming product code DQO, 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
2007810614564
20083804726
20098587933
2010713711556
20116747625
201215942532
20132—1753
201431090601
2015102091 (1)628
20164892 (1)614
2017101761873
2018102342777
2019611371386
20203304 (4)312
20211—0338
202241811379
20234731 (1)391
202441480511
20252—0656
202638524 (4)—

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The DQO category page

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https://510kreport.com/device/K904788 · printed Nov 6, 2026

Cite this page

510(k) Report. “K904788: Mewissen Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K904788

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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