510(k) · Cleared

Recalled · 2006

Bard (R) William Harvey (R) Arterial Straigh Cannula

K930620510(k) TraditionalCleared May 7, 199388-day reviewClass II21 CFR 870.4210Recalls 2

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

C.R. Bard, Inc. · DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Cleared on May 7, 1993 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled 2 times.

Decided: May 7, 1993
Review: 88 days
Class: Class II
Product code: DWF
Recalls: 2
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK930620 Bard (R) William Harvey (R) Arterial Straigh CannulaC.R. Bard, Inc. · 1993
Descendant · cites it directly · 0 of its ownK063618 Tenderflow Periatric Arterial CannulaTerumo Cardiovascular Systems Corp. · 2007 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K063618Tenderflow Periatric Arterial CannulaTerumo Cardiovascular Systems Corp. · 2007 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K930620	Bard (R) William Harvey (R) Arterial Straigh Cannula	C.R. Bard, Inc.	1993	—
+1	K063618	Tenderflow Periatric Arterial Cannula	Terumo Cardiovascular Systems Corp.	2007	24

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0

FIG. 1 — Lineage of K930620, 1993–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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.

Planning a device in DWF? 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 DWF device

#1 K251258 MC2™ Two-Stage Venous Cannula; MC2X™…score 14.6 · 8 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K063618	Tenderflow Periatric Arterial Cannula	Terumo Cardiovascular Systems Corp.	2007	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Dec 7, 2006	Not classified	Z-0544-2007	Other	The cannula connector is an incorrect size: It is actually 1/4" by 3/8" instead of the correct 1/4" by 1/4".
Dec 7, 2006	Not classified	Z-0543-2007	Other	The cannula connector is an incorrect size: It is actually 1/4" by 3/8" instead of the correct 1/4" by 1/4".

No ancestor or descendant has a Class I recall.

What does this lineage say?

Of its descendants, K063618 (Terumo Cardiovascular Systems Corp., 2007) has gone furthest, with 0 descendants of its own.

How does its category compare?

All DWF devices

DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DWF

4in 2025

2007high 14 (2014) · low 2 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DWF

89in 2025

2007high 358 (2021) · low 29 (2024)2026

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

Recalls per year · DWF

4in 2024

2007high 37 (2012) · low 0 (2020)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DWF

1,020in 2025

2007high 1,020 (2025) · low 99 (2009)2025

MAUDE reports naming product code DWF, 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	2	—	25	121
2008	6	95	25	126
2009	8	148	21	99
2010	3	62	26	197
2011	5	85	13	212
2012	10	110	37	233
2013	9	110	14 (1)	238
2014	14	110	6	325
2015	9	46	3 (1)	218
2016	3	32	3	144
2017	5	127	2 (1)	101
2018	5	30	10	118
2019	3	120	2	179
2020	3	30	0	142
2021	5	358	3	162
2022	2	—	0	276
2023	2	—	0	470
2024	3	29	4	401
2025	4	89	0	1,020
2026	8	81	20	—

https://510kreport.com/device/K930620 · printed Nov 5, 2026

Cite this page

510(k) Report. “K930620: Bard (R) William Harvey (R) Arterial Straigh Cannula.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K930620

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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