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FDA 510(k)

COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH

K-Number: K010055 · 2001-06-14

ApplicantCook Vascular, Inc.
Decision Date2001-06-14
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH is the device name listed in this FDA 510(k) record. The listed applicant is Cook Vascular, Inc.. It received FDA 510(k) clearance on 2001-06-14 under 510(k) number K010055. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH?

COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH is a medical device that received FDA 510(k) clearance on 2001-06-14. The listed applicant is Cook Vascular, Inc.. The 510(k) number is K010055.

When did COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH receive FDA 510(k) clearance?

COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH received FDA 510(k) clearance on 2001-06-14, under 510(k) number K010055.

Who is the listed applicant for COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH?

The FDA 510(k) record lists Cook Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH?

The FDA product code for COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH is DRE.

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Other records listing Cook Vascular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K110347DOPPLER MONITORK083482COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SETK081425COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORTK061000EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0K032223COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCHK023937COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM

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Related Devices (Code: DRE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.K253616ProtekDilate Vascular Access KitSorin Group Italia S.R.L.K251325VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K242229Micro Ace Gold Advanced Micro Access SystemMerit Medical Systems, Inc.K241720VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.K233647VersaCross Connect™ Transseptal DilatorBaylis Medical Company, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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