510(k) Report

510(k) · Cleared

Cleared

Docking Station,Teirstein Edge,Angioassist Combination Device, Angioassist Family

K093822510(k) TraditionalCleared Jan 28, 201045-day reviewClass II21 CFR 870.1330

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

Shepherd Scientific, Inc. · DQX Wire, Guide, Catheter

Cleared on Jan 28, 2010 as substantially equivalent to K963171 (Cordis Corp., 1996) and 3 other predicates after a 45-day review. Its family tree reaches back 5 generations to 1997.

Decided
Jan 28, 2010
Review
45 days
Class
Class II
Product code
DQX
Recalls
None
Predicates
4

Its longest line of descent runs back 5 generations to K970376 (1997). 24 ancestors in all, the oldest K854261 (1985). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestor2000: 2 other ancestors1996: 1 other ancestor2006: 1 other ancestor2004: 1 other ancestor2003: 3 other ancestors1991: 2 other ancestors2002: 1 other ancestor2001: 1 other ancestor1999: 1 other ancestor1995: 3 other ancestors1989: 1 other ancestor1985: 1 other ancestorK970376 · Ptca Guidewire · Lake Region Mfg., Inc. · 1997K011968 · Streerable Ptca Guidewire · Lake Region Mfg., Inc. · 2001 · recalledK022813 · Steerable Guidewire · Lake Region Mfg., Inc. · 2003K042338 · Coronary Peripheral and Renal Steerable Guidewire · Lake Region Mfg., Inc. · 2004K062192 · Ostial Pro Stent Positioning System · Ostial Solutions, LLC · 2007198519901995200020052010
Other ancestors, by generation 1 generation back: 3 other ancestors2 generations back: 5 other ancestors3 generations back: 8 other ancestors4 generations back: 3 other ancestors K062192 · Ostial Pro Stent Positioning System · Ostial Solutions, LLC · 2007K042338 · Coronary Peripheral and Renal Steerable Guidewire · Lake Region Mfg., Inc. · 2004K022813 · Steerable Guidewire · Lake Region Mfg., Inc. · 2003K011968 · Streerable Ptca Guidewire · Lake Region Mfg., Inc. · 2001 · recalledK970376 · Ptca Guidewire · Lake Region Mfg., Inc. · 1997−50
  1. Root · 5 generations backK970376 Ptca GuidewireLake Region Mfg., Inc. · 1997
  2. 4 generations backK011968 Streerable Ptca GuidewireLake Region Mfg., Inc. · 2001 · Recalled
  3. 3 generations backK022813 Steerable GuidewireLake Region Mfg., Inc. · 2003
  4. 2 generations backK042338 Coronary Peripheral and Renal Steerable GuidewireLake Region Mfg., Inc. · 2004
  5. 1 generation backK062192 Ostial Pro Stent Positioning SystemOstial Solutions, LLC · 2007
  6. This deviceK093822 Docking Station,Teirstein Edge,Angioassist Combination Device…Shepherd Scientific, Inc. · 2010
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K970376Ptca GuidewireLake Region Mfg., Inc.1997—
−4K011968Streerable Ptca GuidewireLake Region Mfg., Inc.20012
−3K022813Steerable GuidewireLake Region Mfg., Inc.2003—
−2K042338Coronary Peripheral and Renal Steerable GuidewireLake Region Mfg., Inc.2004—
−1K062192Ostial Pro Stent Positioning SystemOstial Solutions, LLC2007—
0 (this device)K093822Docking Station,Teirstein Edge,Angioassist Combination Device, Angioassist…Shepherd Scientific, Inc.2010—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198510
198910
199120
199530
199610
199910
200020
200110
200210
200330
200410
200610
200710
FIG. 1 — Lineage of K093822, 1997–2010Source: 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), 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 DQX? 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 DQX device

  1. #1 K213854 SavvyWirescore 15.7 · 10 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? (5)

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
*K963171Cinch QR SGW Extension
Summary page 1
…of the Act. Predicate Device Manufacturer 510(k) Status Cinch QR Steerable Guidewire Cordis Corporation K963 171 Extension Accessories Ostial Pro Stent Positioning System Ostial Solutions, LLC K062 192 Torque Device…
Cordis Corp.1996—
*K062192Ostial Pro Stent Positioning System
Summary page 1
…ch QR Steerable Guidewire Cordis Corporation K963 171 Extension Accessories Ostial Pro Stent Positioning System Ostial Solutions, LLC K062 192 Torque Device Merit Medical Systems, Inc. K072552 WireClip Torquer Boston Sci…
Ostial Solutions, LLC2007—
*K072552Merit Medical Systems, Inc., Guide Wire Torque Device
Summary page 1
…nsion Accessories Ostial Pro Stent Positioning System Ostial Solutions, LLC K062 192 Torque Device Merit Medical Systems, Inc. K072552 WireClip Torquer Boston Scientific K003398 KEEP Accessory Organizer Merit Medic…
Merit Medical Systems, Inc.2007—
*K003398Wireclip Torquer
Summary page 1
…K062 192 Torque Device Merit Medical Systems, Inc. K072552 WireClip Torquer Boston Scientific K003398 KEEP Accessory Organizer Merit Medical Systems, Inc. Exempt 5.1. Device Description The AngioAssist consi…
Boston Scientific Corporation Northwest Technology2000—
*—KEEP Accessory Organizer
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)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
  • 3 of the 24 ancestors have a recall of any class.

How does its category compare?

All DQX devices

DQX Wire, Guide, Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · DQX

10in 2025

2007: 142008: 192009: 182010: 212011: 182012: 202013: 182014: 182015: 152016: 142017: 192018: 192019: 132020: 142021: 62022: 152023: 102024: 112025: 102026 (partial year): 12
2007high 21 (2010) · low 6 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQX

177in 2025

2007: 85 days median2008: 87 days median2009: 87 days median2010: 63 days median2011: 43 days median2012: 62 days median2013: 119 days median2014: 103 days median2015: 112 days median2016: 179 days median2017: 85 days median2018: 114 days median2019: 173 days median2020: 106 days median2021: 161 days median2022: 212 days median2023: 136 days median2024: 134 days median2025: 177 days median2026 (partial year): 145 days median
2007high 212 (2022) · low 43 (2011)2026

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

Recalls per year · DQX

3in 2024

2007: 122008: 72009: 492010: 342011: 32012: 52013: 7, 4 Class I2015: 12016: 2, 2 Class I2017: 172018: 92019: 22020: 1, 1 Class I2024: 32026 (partial year): 4, 1 Class I
2007high 49 (2009) · low 0 (2014)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · DQX

2,178in 2025

2007: 7602008: 7152009: 6872010: 9872011: 1,3112012: 1,3372013: 1,4742014: 1,3232015: 1,3232016: 1,4662017: 1,5242018: 1,7372019: 1,6792020: 1,5362021: 1,7132022: 1,6472023: 2,0682024: 2,2102025: 2,178
2007high 2,210 (2024) · low 687 (2009)2025

MAUDE reports naming product code DQX, 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
2007148512760
200819877715
2009188749687
2010216334987
2011184331,311
2012206251,337
2013181197 (4)1,474
20141810301,323
20151511211,323
2016141792 (2)1,466
20171985171,524
20181911491,737
20191317321,679
2020141061 (1)1,536
2021616101,713
20221521201,647
20231013602,068
20241113432,210
20251017702,178
2026121454 (1)—

What is it indicated for?

The AngioAssist is a set of manual instruments intended to facilitate alignment and introduction of interventional devices (i.e., guide wires and catheters) within the coronary and peripheral vasculature.

Indications for use as stated in the FDA summary.

Recent decisions in DQX

The DQX category page

  • K260168Small Diameter Core Wire (CMAN-000-00); Small Diameter Core Wire (CMAN-000-14)Skycade Med Corporation · 2026
  • K253146Hyperdrive 35 GuidewireRapid-Medical, Ltd. · 2026
  • K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd. · 2026
  • K253667Accoat Guide WireSp Medical A/S · 2026
  • K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland, Ltd. · 2026

https://510kreport.com/device/K093822 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093822: Docking Station,Teirstein Edge,Angioassist Combination Device, Angioassist Family.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093822

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