510(k) Report

510(k) · Cleared

Cleared

Amplatzer Torqvue Low Profile Delivery System

K080757510(k) SpecialCleared Apr 18, 200831-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

Aga Medical Corp. · DQY Catheter, Percutaneous

Cleared on Apr 18, 2008 as substantially equivalent to K072313 (Aga Medical Corp., 2007) after a 31-day review. Its family tree reaches back 7 generations to 1989. 7 later devices descend from it.

Decided
Apr 18, 2008
Review
31 days
Class
Class II
Product code
DQY
Recalls
None
Predicates
1

Its longest line of descent runs back 7 generations to K893658 (1989). 39 ancestors in all, the oldest K770977 (1977). 7 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2001: 2 other ancestors1999: 2 other ancestors1995: 3 other ancestors1994: 4 other ancestors1996: 2 other ancestors1990: 5 other ancestors1993: 1 other ancestor1992: 3 other ancestors1991: 1 other ancestor1988: 1 other ancestor1987: 3 other ancestors1986: 1 other ancestor1985: 2 other ancestors1977: 1 other ancestor2009: 1 descendant cleared2013: 1 descendant cleared2016: 1 descendant cleared2024: 2 descendants cleared2026: 1 descendant cleared2025: 1 descendant clearedK893658 · Percutaneous Introducer · Medamicus, Inc. · 1989K965167 · Percutaneous Venous Introducer 10264 · Medamicus, Inc. · 1997K012130 · Attain LDS 6216 Left-Heart Delivery System · Medtronic Vascular · 2001K013517 · 10600 Deflectable Catheter System, Model 10600 · Medtronic Vascular · 2002×2: 2 generations cleared close together, K032312 (2003), K033989 (2004) K072313 · Amplatzer Torqvue Delivery System · Aga Medical Corp. · 2007 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 3 generations back: 1 other ancestor4 generations back: 5 other ancestors5 generations back: 5 other ancestors6 generations back: 21 other ancestors 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 2 descendants K072313 · Amplatzer Torqvue Delivery System · Aga Medical Corp. · 2007 · recalledK033989 · Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69 · Medtronic Inc. Cardiac Rhythm Management · 2004K032312 · Attain 6226DEF Deflectable Catheter Delivery System · Medtronic Vascular · 2003K013517 · 10600 Deflectable Catheter System, Model 10600 · Medtronic Vascular · 2002K012130 · Attain LDS 6216 Left-Heart Delivery System · Medtronic Vascular · 2001K965167 · Percutaneous Venous Introducer 10264 · Medamicus, Inc. · 1997K893658 · Percutaneous Introducer · Medamicus, Inc. · 1989−50
  1. Root · 7 generations backK893658 Percutaneous IntroducerMedamicus, Inc. · 1989
  2. 6 generations backK965167 Percutaneous Venous Introducer 10264Medamicus, Inc. · 1997
  3. 5 generations backK012130 Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular · 2001
  4. 4 generations backK013517 10600 Deflectable Catheter System, Model 10600Medtronic Vascular · 2002
  5. 3 generations backK032312 Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular · 2003
  6. 2 generations backK033989 Medtronic Selectsite Deflectable Catheter System, Models C304-S59…Medtronic Inc. Cardiac Rhythm Management · 2004
  7. 1 generation backK072313 Amplatzer Torqvue Delivery SystemAga Medical Corp. · 2007 · Recalled
  8. This deviceK080757 Amplatzer Torqvue Low Profile Delivery SystemAga Medical Corp. · 2008
  9. Descendant · cites it directly · 5 of its ownK131063 Amplatzer Torq Vue LP Delivery SystemSt Jude Medical · 2013 · Recalled
  10. Descendant · 2 generations on · 2 of its ownK162228 TorqVue Low Profile Delivery CatheterAga Medical Corporation (Wholly Owned by St.Jude Medical Cor · 2016 · Recalled
  11. Descendant · 2 generations on · 1 of its ownK241538 TriClip Steerable Guide CatheterAbbott Medical · 2024
  12. Descendant · 2 generations on · 0 of its ownK261825 Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott · 2026
  13. Descendant · 3 generations on · 0 of its ownK252417 Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)Abbott Medical · 2025

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2009: 12013: 12016: 12024: 22025: 12026: 1
2009high 2 (2024) · low 0 (2010)2026

Most influential descendants

Showing 5 of 7 · See all
  • K131063Amplatzer Torq Vue LP Delivery SystemSt Jude Medical · 2013 · cites it directly5descendants
  • K162228TorqVue Low Profile Delivery CatheterAga Medical Corporation (Wholly Owned by St.Jude Medical Cor · 2016 · 2 generations on2descendants
  • K241538TriClip Steerable Guide CatheterAbbott Medical · 2024 · 2 generations on1descendant
  • K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott · 2026 · 2 generations on0descendants
  • K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)Abbott Medical · 2025 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K893658Percutaneous IntroducerMedamicus, Inc.1989—
−6K965167Percutaneous Venous Introducer 10264Medamicus, Inc.1997—
−5K012130Attain LDS 6216 Left-Heart Delivery SystemMedtronic Vascular2001—
−4K01351710600 Deflectable Catheter System, Model 10600Medtronic Vascular2002—
−3K032312Attain 6226DEF Deflectable Catheter Delivery SystemMedtronic Vascular2003—
−2K033989Medtronic Selectsite Deflectable Catheter System, Models C304-S59 and C304-L69Medtronic Inc. Cardiac Rhythm Management2004—
−1K072313Amplatzer Torqvue Delivery SystemAga Medical Corp.20071
0 (this device)K080757Amplatzer Torqvue Low Profile Delivery SystemAga Medical Corp.2008—
+1K131063Amplatzer Torq Vue LP Delivery SystemSt Jude Medical20131
+2K162228TorqVue Low Profile Delivery CatheterAga Medical Corporation (Wholly Owned by St.Jude Medical Cor20161
+2K241538TriClip Steerable Guide CatheterAbbott Medical2024—
+2K261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbott2026—
+3K252417Amplatzer Piccolo™ Delivery System (9-PDS-04F-045)Abbott Medical2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197710
198520
198610
198730
198810
199050
199110
199230
199310
199440
199530
199620
199920
200120
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201310
201610
202420
202510
202610
FIG. 1 — Lineage of K080757, 1989–2026Source: 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), 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 DQY? 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? (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
*K072313Amplatzer Torqvue Delivery System
Summary page 1
…Class II, 21 CFR 870.1250 Product Code: DQY Predicate Device: AMPLATZER® TorqVue® Delivery System 5 10(k) K072313, Reg. No. 870.1250; Product Code: DQY Predicate Device Intended Use: The AMPLATZER®…
Aga Medical Corp.20071

Also cleared against K072313: 10 other devices →

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K131063Amplatzer Torq Vue LP Delivery SystemSt Jude Medical20135
K091793Amplatzer Torqvue 3 Delivery Sheath, Model 9-TV3-08F104, 9-TV3-08F54Aga Medical Corp.20090

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 19 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
  • 6 of the 39 ancestors have a recall of any class.
  • Of its descendants, K131063 (St Jude Medical, 2013) has gone furthest, with 5 descendants of its own.
  • 10 other devices also cite its predicate K072313.

How does its category compare?

All DQY devices

DQY Catheter, Percutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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)—

What is it indicated for?

The AMPLATZER® TorqVue® Low Profile Delivery System is indicated to provide a pathway through which devices are introduced into the peripheral vasculature.

Indications for use as stated in the FDA summary.

Also cleared against K072313

10 other devices cite the same predicate.

  • K260993Amplatzer TorqVue Delivery SystemAbbott · 2026
  • K202610Ventrax Delivery SystemMerit Medical Systems, Inc. · 2020
  • K190581Amplatzer Trevisio Intravascular Delivery SystemAbbott Medical · 2019
  • K131063Amplatzer Torq Vue LP Delivery SystemSt Jude Medical · 20131 recall
  • K121611Amplatzer Torqvue FXAga Medical Corporation · 20121 Class I recall
  • K100184Fustar Steerable IntroducersLifetech Scientific (Shenzhen) Co., Ltd. · 2011

More from Aga Medical Corp.

14 FDA decisions under this applicant name. See the company

  • K113658Amplatzer Vascular Plug 4Aga Medical Corp. · 2012
  • K093476Amplatzer Torq Vue 2 Delivery Sheath Model 9-TV2-05F120, Model 9-TV2-06F120, Modeltv-2-07F120Aga Medical Corp. · 2010
  • K091793Amplatzer Torqvue 3 Delivery Sheath, Model 9-TV3-08F104, 9-TV3-08F54Aga Medical Corp. · 2009
  • K083214Amplatzer Torqvue 45DEGREEX45DEGREE Delivery Sheath, Models 9-TV45X45-09F-100, 9-TV45X45-10F-100Aga Medical Corp. · 2009
  • K080994Amplatzer Torqvue Exchange SystemAga Medical Corp. · 2008

Recent decisions in DQY

The DQY category page

  • K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc. · 2026
  • K260559NHanceITIMDS Operation B.V. · 2026
  • K262392APRO 35 Swift CatheterAlembic, LLC · 2026
  • K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC · 2026
  • K262240SSPC NXT Delivery CatheterCenterPoint Systems, LLC · 2026

https://510kreport.com/device/K080757 · printed Nov 3, 2026

Cite this page

510(k) Report. “K080757: Amplatzer Torqvue Low Profile Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080757

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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