510(k) Report

510(k) · Cleared

Cleared

Viking Optima Guiding Catheter

K001435510(k) SpecialCleared Jun 2, 200025-day reviewClass II21 CFR 870.1250

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

Guidant Corp. · DQY Catheter, Percutaneous

Cleared on Jun 2, 2000 after a 25-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 109 devices in its family, counting itself, has a Class I recall. 108 later devices descend from it.

Decided
Jun 2, 2000
Review
25 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
0

108 later devices descend from it, 3 citing it directly. 1 of the 109 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2001: 2 descendants cleared2002: 1 descendant cleared2009: 8 descendants cleared2005: 1 descendant cleared2007: 1 descendant cleared2010: 6 descendants cleared2011: 5 descendants cleared2012: 14 descendants cleared2013: 3 descendants cleared2014: 6 descendants cleared, 1 with a Class I recall12020: 7 descendants cleared2015: 5 descendants cleared2016: 10 descendants cleared2017: 9 descendants cleared2019: 4 descendants cleared2023: 4 descendants cleared2021: 6 descendants cleared2022: 3 descendants cleared2018: 4 descendants cleared2026: 3 descendants cleared2024: 2 descendants cleared2025: 4 descendants cleared200020052010201520202025
  1. This deviceK001435 Viking Optima Guiding CatheterGuidant Corp. · 2000
  2. Descendant · cites it directly · 105 of its ownK011562 Lumend Percutaneous CatheterLumend, Inc. · 2002
  3. Descendant · 2 generations on · 80 of its ownK052258 Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 2005
  4. Descendant · 3 generations on · 44 of its ownK070372 Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support…Vascular Solutions, Inc. · 2007
  5. Descendant · 3 generations on · 35 of its ownK082337 Minnie Support CatheterVascular Solutions, Inc. · 2009
  6. Descendant · 2 generations on · 24 of its ownK080987 Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · Recalled

Showing 5 of 108 descendants. See all descendants

Descendants cleared per year

2001: 22002: 12005: 12007: 12009: 82010: 62011: 52012: 142013: 32014: 62015: 52016: 102017: 92018: 42019: 42020: 72021: 62022: 32023: 42024: 22025: 42026: 3
2001high 14 (2012) · low 0 (2003)2026

Class I recalls in this family

  • K141547 Wingman Extendable Tip Support Catheter8 generations on · 2014

Most influential descendants

Showing 5 of 108 · See all
  • K011562Lumend Percutaneous CatheterLumend, Inc. · 2002 · cites it directly105descendants
  • K052258Vascular Solutions Skyway Support CatheterVascular Solutions, Inc. · 2005 · 2 generations on80descendants
  • K070372Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model 5610Vascular Solutions, Inc. · 2007 · 3 generations on44descendants
  • K082337Minnie Support CatheterVascular Solutions, Inc. · 2009 · 3 generations on35descendants
  • K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical · 2009 · 2 generations on24descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K001435Viking Optima Guiding CatheterGuidant Corp.2000—
+1K011562Lumend Percutaneous CatheterLumend, Inc.2002—
+2K052258Vascular Solutions Skyway Support CatheterVascular Solutions, Inc.2005—
+3K070372Gopher 2F Support Catheter, Model 5600 and Gopher 3F Support Catheter, Model…Vascular Solutions, Inc.2007—
+3K082337Minnie Support CatheterVascular Solutions, Inc.2009—
+2K080987Bridgepoint Medical Stingray Device and AccessoriesBridgepoint Medical20091

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200120
200210
200510
200710
200980
201060
201150
2012140
201330
201461
201550
2016100
201790
201840
201940
202070
202160
202230
202340
202420
202540
202630
FIG. 1 — Lineage of K001435, 2000–2026Source: 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.

1 device in this family has 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 DQY device

  1. #1 K234115 APRO 55 Catheterscore 17.5 · 6 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? (108)

See all 108

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

NumberDeviceApplicantDecidedDescendants
K011562Lumend Percutaneous CatheterLumend, Inc.2002105
K013638Modification to Viking Optima Guiding CatheterGuidant Corp.20010
K012002Viking Optima Guiding CatheterGuidant Corp.20010

Has anything in its family been recalled? (1 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.

  • K141547Wingman Extendable Tip Support CatheterReflow Medical · 2014 · 8 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K011562 (Lumend, Inc., 2002) has gone furthest, with 105 descendants of its own.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQY

21in 2025

2007: 162008: 312009: 372010: 222011: 362012: 302013: 322014: 192015: 272016: 222017: 262018: 252019: 302020: 202021: 182022: 182023: 182024: 162025: 212026 (partial year): 11
2007high 37 (2009) · low 16 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQY

115in 2025

2007: 85 days median2008: 66 days median2009: 73 days median2010: 74 days median2011: 71 days median2012: 87 days median2013: 92 days median2014: 127 days median2015: 118 days median2016: 117 days median2017: 113 days median2018: 106 days median2019: 111 days median2020: 120 days median2021: 81 days median2022: 74 days median2023: 114 days median2024: 87 days median2025: 115 days median2026 (partial year): 30 days median
2007high 127 (2014) · low 66 (2008)2026

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

Recalls per year · DQY

1in 2025

2007: 62008: 122009: 172010: 322011: 62012: 22013: 36, 1 Class I2014: 32015: 32016: 22, 7 Class I2017: 82018: 22019: 12020: 22021: 22023: 172024: 12025: 1, 1 Class I2026 (partial year): 2, 1 Class I
2007high 36 (2013) · low 0 (2022)2026

Class I (10 since 2007) Class II/III not classified

Adverse event reports per year · DQY

3,056in 2025

2007: 3132008: 4962009: 8192010: 1,2932011: 1,2112012: 1,1912013: 1,3522014: 1,4972015: 2,3372016: 2,2522017: 2,4892018: 2,8552019: 2,9022020: 2,8892021: 3,0062022: 2,6432023: 3,0492024: 3,1902025: 3,056
2007high 3,190 (2024) · low 313 (2007)2025

MAUDE reports naming product code DQY, 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
200716856313
2008316612496
2009377317819
20102274321,293
2011367161,211
2012308721,191
2013329236 (1)1,352
20141912731,497
20152711832,337
20162211722 (7)2,252
20172611382,489
20182510622,855
20193011112,902
20202012022,889
2021188123,006
2022187402,643
202318114173,049
2024168713,190
2025211151 (1)3,056
202611302 (1)—

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The DQY category page

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https://510kreport.com/device/K001435 · printed Nov 6, 2026

Cite this page

510(k) Report. “K001435: Viking Optima Guiding Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K001435

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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