510(k) · Cleared

Cleared

Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters

K072947510(k) TraditionalCleared Feb 8, 2008113-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

ClearStream Technologies, Ltd. · LIT Catheter, Angioplasty, Peripheral, Transluminal

Cleared on Feb 8, 2008 as substantially equivalent to K042537 (Invatec Innovative Technologies, 2004) after a 113-day review. Its family tree reaches back 1 generation to 2004. 79 later devices descend from it.

Decided: Feb 8, 2008
Review: 113 days
Class: Class II
Product code: LIT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K042537 (2004). 79 later devices descend from it, 7 citing it directly.

By dateBy generation

Root · 1 generation backK042537 Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter…Invatec Innovative Technologies · 2004
This deviceK072947 Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta)…ClearStream Technologies, Ltd. · 2008
Descendant · cites it directly · 35 of its ownK082579 Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · Recalled
Descendant · cites it directly · 26 of its ownK083919 Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 2009 · Recalled
Descendant · 2 generations on · 14 of its ownK093286 Powercross .018 Otw Pta Dilation CatheterEv3, Inc. · 2009 · Recalled
Descendant · cites it directly · 12 of its ownK100490 Litepac, Model 682ClearStream Technologies, Ltd. · 2010
Descendant · 2 generations on · 11 of its ownK131199 Ultraverse RX Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2013

Showing 5 of 79 descendants. See all descendants

Descendants cleared per year

2008high 9 (2016) · low 1 (2008)2026

Most influential descendants

Showing 5 of 79 · See all

K082579Evercross .035 Otw Pta Dilatation CatheterEv3, Inc. · 2008 · cites it directly35descendants
K083919Amphirion Deep 0.014 Otw Pta Balloon CatheterInvatec Innovative Technologies, S.R.L. · 2009 · cites it directly26descendants
K093286Powercross .018 Otw Pta Dilation CatheterEv3, Inc. · 2009 · 2 generations on14descendants
K100490Litepac, Model 682ClearStream Technologies, Ltd. · 2010 · cites it directly12descendants
K131199Ultraverse RX Pta Balloon Dilatation CatheterBard Peripheral Vascular, Inc. · 2013 · 2 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K042537	Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model…	Invatec Innovative Technologies	2004	—
0 (this device)	K072947	Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters	ClearStream Technologies, Ltd.	2008	—
+1	K082579	Evercross .035 Otw Pta Dilatation Catheter	Ev3, Inc.	2008	1
+1	K083919	Amphirion Deep 0.014 Otw Pta Balloon Catheter	Invatec Innovative Technologies, S.R.L.	2009	1
+2	K093286	Powercross .018 Otw Pta Dilation Catheter	Ev3, Inc.	2009	2
+1	K100490	Litepac, Model 682	ClearStream Technologies, Ltd.	2010	—
+2	K131199	Ultraverse RX Pta Balloon Dilatation Catheter	Bard Peripheral Vascular, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2008	1	0
2009	4	0
2010	7	0
2011	8	0
2012	6	0
2013	7	0
2014	3	0
2015	8	0
2016	9	0
2017	4	0
2018	1	0
2019	3	0
2020	5	0
2021	3	0
2022	3	0
2023	1	0
2024	1	0
2025	1	0
2026	4	0

FIG. 1 — Lineage of K072947, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K241040 Amethyst HP PTA OTW 0.035 Catheterscore 13.9 · 9 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K042537	Submarine Plus Percutaneous Transluminal Angioplasty (Pta) Catheter, Model Suvxxxxxxxxx Summary page 1 …dicate Device Information: Device Name: Submarine Plus Percutaneous Transluminal Angioplasty (PTA) Catheters Manufacturer: Invatec Innovative Technologies Reference: K042537 Device Description: A family of semi-compliant coaxial design catheters in various sizes. Each catheter has a balloon mounted on…	Invatec Innovative Technologies	2004	—

Also cleared against K042537: 3 other devices →

What descends from it? (79)

See all 79

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

Number	Device	Applicant	Decided	Descendants
K082579	Evercross .035 Otw Pta Dilatation Catheter	Ev3, Inc.	2008	35
K083919	Amphirion Deep 0.014 Otw Pta Balloon Catheter	Invatec Innovative Technologies, S.R.L.	2009	26
K100490	Litepac, Model 682	ClearStream Technologies, Ltd.	2010	12
K112797	Powerflex Pro Percutaneous Transluminal Angioplasty Catheter	Cordis Corp.	2012	10
K093139	Bantam,48XXXXXX, 50XXXXXX	ClearStream Technologies, Ltd.	2009	9
K083596	Reekross Family or Otw Pta Catheters	ClearStream Technologies, Ltd.	2009	1
K221832	SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter	Cordis US Corp	2022	0

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?

Its one ancestor has no recall.
Of its descendants, K082579 (Ev3, Inc., 2008) has gone furthest, with 35 descendants of its own.
3 other devices also cite its predicate K042537.

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. 2008, this device’s year, is highlighted.

FDA decisions per year · LIT

3in 2025

2007high 19 (2012) · low 3 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LIT

90in 2025

2007high 205 (2026) · low 29 (2009)2026

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

Recalls per year · LIT

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	64	0	577
2008	8	53	0	513
2009	7	29	2	623
2010	13	78	1	809
2011	10	82	0	857
2012	19	29	0	1,277
2013	14	79	2 (2)	1,242
2014	12	90	3	1,178
2015	19	112	0	1,279
2016	11	116	1	1,529
2017	9	57	0	2,081
2018	6	118	2	2,188
2019	4	40	3	2,405
2020	9	125	0	2,443
2021	4	61	1	2,492
2022	8	122	0	2,155
2023	6	167	0	1,807
2024	6	43	2	1,913
2025	3	90	1	2,073
2026	4	205	0	—

What is it indicated for?

Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K072947 · printed Nov 4, 2026

Cite this page

510(k) Report. “K072947: Savvy Long and Sleek Peripheral Transluminal Angioplasty (Pta) Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072947

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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