510(k) Report

510(k) · Cleared

Cleared

Atb Advance Pta Dilatation Catheter

K113300510(k) SpecialCleared Dec 9, 201130-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

Cook, Inc. · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on Dec 9, 2011 as substantially equivalent to K033875 (Cook, Inc., 2004) and 2 other predicates after a 30-day review. Its family tree reaches back 3 generations to 1997.

Decided
Dec 9, 2011
Review
30 days
Class
Class II
Product code
LIT
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K970299 (1997). 10 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2006: 1 other ancestor2005: 1 other ancestor2003: 2 other ancestors2002: 2 other ancestors1997: 1 other ancestorK970299 · Jupiter Pta Catheters (Various) · Cordis Corp. · 1997K983055 · RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 · Guidant Corp. · 1998K033875 · Atb All-Terrain Balloon Pta Dilatation Catheter · Cook, Inc. · 20041995200020052010
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors3 generations back: 1 other ancestor K033875 · Atb All-Terrain Balloon Pta Dilatation Catheter · Cook, Inc. · 2004K983055 · RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 · Guidant Corp. · 1998K970299 · Jupiter Pta Catheters (Various) · Cordis Corp. · 19970
  1. Root · 3 generations backK970299 Jupiter Pta Catheters (Various)Cordis Corp. · 1997
  2. 2 generations backK983055 RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20…Guidant Corp. · 1998
  3. 1 generation backK033875 Atb All-Terrain Balloon Pta Dilatation CatheterCook, Inc. · 2004
  4. This deviceK113300 Atb Advance Pta Dilatation CatheterCook, Inc. · 2011
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K970299Jupiter Pta Catheters (Various)Cordis Corp.1997—
−2K983055RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20…Guidant Corp.1998—
−1K033875Atb All-Terrain Balloon Pta Dilatation CatheterCook, Inc.2004—
0 (this device)K113300Atb Advance Pta Dilatation CatheterCook, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199710
200220
200320
200510
200610
FIG. 1 — Lineage of K113300, 1997–2011Source: 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 LIT? 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 LIT device

  1. #1 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 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? (3)

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
*K033875Atb All-Terrain Balloon Pta Dilatation Catheter
Summary page 1
…expandable peripheral vascular stents. Predicate Devices: AID Advance® PTA Dilatation Catheter cleared under the following 510(k) Premarket Notifications: * D.C.#K033875, April 2, 2004 * D.C.#K052036, August 25, 2005 * D.C.#K063252, November 14, 2006 Device Description: The AIR Advance…
Cook, Inc.2004—
*K052036Atb Advance Pta Dilatation Catheter
Summary page 1
…s. Predicate Devices: AID Advance® PTA Dilatation Catheter cleared under the following 510(k) Premarket Notifications: * D.C.#K033875, April 2, 2004 * D.C.#K052036, August 25, 2005 * D.C.#K063252, November 14, 2006 Device Description: The AIR Advance®'PTA Dilatation Catheter is an over…
Cook, Inc.20051
*K063252Atb Advanced Pta Dilatation Catheter
Summary page 1
…A Dilatation Catheter cleared under the following 510(k) Premarket Notifications: * D.C.#K033875, April 2, 2004 * D.C.#K052036, August 25, 2005 * D.C.#K063252, November 14, 2006 Device Description: The AIR Advance®'PTA Dilatation Catheter is an over-the-wire catheter indicated for percu…
Cook, Inc.2006—

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 14 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
  • 2 of the 10 ancestors have a recall of any class.

How does its category compare?

All LIT devices

LIT Catheter, Angioplasty, Peripheral, Transluminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · LIT

3in 2025

2007: 62008: 82009: 72010: 132011: 102012: 192013: 142014: 122015: 192016: 112017: 92018: 62019: 42020: 92021: 42022: 82023: 62024: 62025: 32026 (partial year): 4
2007high 19 (2012) · low 3 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIT

90in 2025

2007: 64 days median2008: 53 days median2009: 29 days median2010: 78 days median2011: 82 days median2012: 29 days median2013: 79 days median2014: 90 days median2015: 112 days median2016: 116 days median2017: 57 days median2018: 118 days median2019: 40 days median2020: 125 days median2021: 61 days median2022: 122 days median2023: 167 days median2024: 43 days median2025: 90 days median2026 (partial year): 205 days median
2007high 205 (2026) · low 29 (2009)2026

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

Recalls per year · LIT

1in 2025

2009: 22010: 12013: 2, 2 Class I2014: 32016: 12018: 22019: 32021: 12024: 22025: 1
2007high 3 (2014) · low 0 (2007)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · LIT

2,073in 2025

2007: 5772008: 5132009: 6232010: 8092011: 8572012: 1,2772013: 1,2422014: 1,1782015: 1,2792016: 1,5292017: 2,0812018: 2,1882019: 2,4052020: 2,4432021: 2,4922022: 2,1552023: 1,8072024: 1,9132025: 2,073
2007high 2,492 (2021) · low 513 (2008)2025

MAUDE reports naming product code LIT, 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
20076640577
20088530513
20097292623
201013781809
201110820857
2012192901,277
201314792 (2)1,242
2014129031,178
20151911201,279
20161111611,529
201795702,081
2018611822,188
201944032,405
2020912502,443
202146112,492
2022812202,155
2023616701,807
202464321,913
202539012,073
202642050—

What is it indicated for?

For percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries including iliac, renal, popliteal, infrapopliteal, femoral and iliofemoral as well as obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The AIB Advance® PTA Dilatation Catheter (ATB) is also intended for post dilatation of balloon-expandable peripheral vascular stents.

Indications for use as stated in the FDA summary.

More from Cook, Inc.

285 FDA decisions under this applicant name. See the company

  • P020018/S070Zenith Fenestrated AAA Endovascular Graft, Zenith Iliac BranchCook, Inc. · 2026
  • P020018/S069Zenith® Flex AAA Endovascular System; Zenith Fenestrated AAA Endovascular Graft (ZFEN); Zenith Iliac Branch…Cook, Inc. · 2026
  • P020018/S068Zenith (Flex) AAA Endovascular Graft; Zenith Renu AAA Ancillary Graft; Zenith Fenestrated AAA Endovascular…Cook, Inc. · 2026
  • P020018/S067Zenith Flex AAA Endovascular Graft Bifurcated Main Body; Zenith Renu AAA Ancillary Graft Converter; Zenith…Cook, Inc. · 2026
  • P020018/S066Zenith Flex AAA Endovascular System and Zenith Iliac BranchCook, Inc. · 2026

Recent decisions in LIT

The LIT category page

  • K260416ZYLOX Hippo PTA Balloon Dilatation CatheterZylox Medtech Co., Ltd. · 2026
  • K254212NC PTA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd. · 2026
  • K260304WAVE PTA Balloon CatheterWAVE Medical AG · 2026
  • K252512Armada™ 14 NC PTA CatheterAbbott Medical · 2026
  • K251915Amethyst HP PTA OTW 0.035 CatheterNatec Medical, Ltd. · 2025

https://510kreport.com/device/K113300 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113300: Atb Advance Pta Dilatation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113300

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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